Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate the therapeutic applications of ondansetron, primarily focusing on post-operative nausea and vomiting, chemotherapy-induced nausea and vomiting, and gastrointestinal disturbances, alongside exploratory studies into alcohol use disorder and bipolar disorder. Sponsored predominantly by academic institutions such as Yonsei University, Mahidol University, and the Milton S. Hershey Medical Center, these trials exhibit recruitment statuses ranging from actively recruiting to completed and terminated. These efforts reflect ongoing initiatives to optimize antiemetic regimens while investigating secondary clinical indications.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07777276 | NOT_YET_RECRUITING | Postoperative Sleep Quality; Postoperative Behaviour; Postoperative Recovery in Children; Postoperative Nausea and Vomiting (PONV); Paediatric Surgery; Anaesthesia |
Telethon Kids Institute |
2026-08-17 | PHASE4 |
| NCT07588217 | NOT_YET_RECRUITING | ARDS (Acute Respiratory Distress Syndrome); Invasive Mechanical Ventilation; Patient-Self Inflicted Lung Injury |
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal |
2026-10-01 | PHASE2; PHASE3 |
| NCT05784350 | NOT_YET_RECRUITING | Intra-operative Hypotension |
Meir Medical Center |
2025-08-01 | |
| NCT03865290 | RECRUITING | Indigestion; Diabetes Mellitus |
Mayo Clinic |
2019-04-02 | PHASE2 |
| NCT05844501 | RECRUITING | Atrial Fibrillation |
Indiana University |
2025-04-22 | PHASE4 |
| NCT07795060 | NOT_YET_RECRUITING | Cholera (Disorder) |
Public Interest Science Center |
2027-03-01 | PHASE2 |
| NCT07699276 | RECRUITING | Cancer (Solid Tumors); Vomiting; Cisplatin; Olanzapine |
Mahidol University |
2026-02-10 | PHASE2 |
| NCT06588413 | RECRUITING | Multiple Myeloma; Autologous Stem Cell Transplantation |
Augusta University |
2024-09-17 | PHASE3 |
| NCT06904235 | RECRUITING | Nausea and Vomiting Chemotherapy-Induced; Nausea Post Chemotherapy |
Helsinn Healthcare SA |
2025-07-07 | PHASE2 |
| NCT07793760 | NOT_YET_RECRUITING | Preeclampsia; Spinal Anesthesia-Induced Hypotension; Cesarean Section |
Assiut University |
2026-10 | PHASE4 |
| NCT03817970 | ACTIVE_NOT_RECRUITING | Nephrotoxicity |
University of Colorado, Denver |
2019-11-15 | PHASE3 |
| NCT07662200 | NOT_YET_RECRUITING | Germ Cell Cancer |
Ottawa Hospital Research Institute |
2026-08 | EARLY_PHASE1 |
| NCT07639723 | NOT_YET_RECRUITING | PONV |
Endeavor Health |
2026-07 | PHASE4 |
| NCT06887621 | RECRUITING | Post Operative Nausea and Vomiting (PONV) |
Instituto do Cancer do Estado de São Paulo |
2025-04-10 | PHASE2 |
| NCT06382012 | RECRUITING | Nausea and Vomiting; Nausea; Vomiting |
Montefiore Medical Center |
2024-11-13 | PHASE2; PHASE3 |
| NCT07638527 | RECRUITING | Postoperative Nausea and Vomiting |
Faisalabad Medical University |
2026-09 | PHASE4 |
| NCT06810882 | RECRUITING | Ondansetron; Laparoscopic; Gastrectomy |
Tanta University |
2025-02-16 | |
| NCT07740577 | RECRUITING | Intraoperative Nausea-retching-vomiting Episodes; Spinal Aneshtesia; Ceserean Section; Antiemetic Therapy; Ondansetron; Metoclopramide |
Sanliurfa Education and Research Hospital |
2026-07-30 | PHASE4 |
| NCT05657925 | NOT_YET_RECRUITING | Sleep Syncope |
University of Calgary |
2024-12-01 | PHASE3 |
| NCT07381634 | RECRUITING | Hepatocellular Carcinoma (HCC); IrAE |
First Affiliated Hospital of Wenzhou Medical University |
2026-04-30 | PHASE2 |
| NCT06861010 | RECRUITING | Pancreatic Diseases |
Tanta University |
2025-03-01 | PHASE3 |
| NCT06704139 | NOT_YET_RECRUITING | Cesarean Section |
Assiut University |
2024-12-01 | PHASE4 |
| NCT06727201 | NOT_YET_RECRUITING | Spinal Anaesthesia Induced Hypotension |
Assiut University |
2025-01-01 | PHASE2; PHASE3 |
| NCT07681076 | NOT_YET_RECRUITING | Healthy Volunteers |
Karuna Therapeutics, Inc., a Bristol Myers Squibb company |
2026-08-03 | PHASE4 |
| NCT07768124 | RECRUITING | Lung Cancer (Diagnosis)Chemotherapy-Induced Nausea and Vomiting |
Xiu Huang |
2026-07-15 | |
| NCT07489742 | RECRUITING | Ondansetron; Lozenge; Intravenous; Shivering; Tonsillectomy |
Tanta University |
2026-03-25 | |
| NCT07511491 | RECRUITING | Ondansetron; Lozenge; Intravenous; Prevention; Shivering; Cesarean Section |
Tanta University |
2026-04-11 | |
| NCT07246070 | NOT_YET_RECRUITING | Chemotherapy-Induced Nausea and Vomiting (CINV) |
AIPING ZHOU |
2025-12 | PHASE2 |
| NCT07632144 | NOT_YET_RECRUITING | Anesthesia Induction; Propofol Pain Injection |
Mongi Slim Hospital |
2026-06-08 | |
| NCT07377903 | NOT_YET_RECRUITING | Shivering, Spinal Anesthesia |
Sohag University |
2026-02-01 | |
| NCT07037654 | ACTIVE_NOT_RECRUITING | Hypotension After Spinal Anesthesia |
Suez Canal University |
2025-06-01 | |
| NCT06208917 | RECRUITING | Pediatric Solid Tumor, Unspecified, Protocol Specific |
Yizhuo Zhang |
2023-07-09 | PHASE3 |
| NCT04150614 | RECRUITING | Nausea With Vomiting Chemotherapy-Induced |
University of Illinois at Chicago |
2020-05-14 | PHASE4 |
| NCT05418244 | RECRUITING | Vomiting; Nausea; Children, Only |
State University of New York at Buffalo |
2022-04-20 | PHASE2; PHASE3 |
| NCT07668700 | COMPLETED | Postoperative Nausea and Vomiting (PONV); Gynecological Laparoscopic Surgery; Anesthesia Complications |
Hameed Latif Hospital, Lahore |
2025-12-02 | PHASE2 |
| NCT07336680 | NOT_YET_RECRUITING | Esophagogastroduodenoscopy; Upper Gastrointestinal Bleeding (UGIB) |
Peking Union Medical College Hospital |
2026-01-01 | PHASE4 |
| NCT06632184 | ACTIVE_NOT_RECRUITING | Postoperative Pain Management; Laparoscopic Cholecystectomy; Ondansetron; Postoperative Nausea and Vomiting |
Instituto Mexicano del Seguro Social |
2025-12-01 | PHASE4 |
| NCT07103720 | COMPLETED | Allergy |
Mayo Clinic |
2025-11-05 | PHASE4 |
| NCT07217600 | RECRUITING | Radiotherapy-induced Nausea and Vomiting (RINV); Pediatric Cancer |
Chongqing University Cancer Hospital |
2025-03-25 | PHASE4 |
| NCT07201883 | ACTIVE_NOT_RECRUITING | Postoperative Nausea and Vomiting (PONV) |
Makassed General Hospital |
2025-08-22 | PHASE1 |
| NCT06850454 | RECRUITING | Chemotherapy Induced Nausea and Vomiting |
Mahidol University |
2025-01-10 | PHASE3 |
| NCT06241547 | COMPLETED | Postoperative Nausea and Vomiting |
Peking Union Medical College Hospital |
2024-02-05 | PHASE2 |
| NCT06747975 | NOT_YET_RECRUITING | Caudal Anesthesia |
Assiut University |
2025-01-01 | PHASE4 |
| NCT06729307 | NOT_YET_RECRUITING | Esophagogastroduodensocopy (EGD) Procedure |
Peking Union Medical College Hospital |
2025-01 | PHASE4 |
| NCT05755737 | RECRUITING | Vasovagal Syncope (VVS); Syncope |
University of Calgary |
2023-06-01 | PHASE2 |
| NCT03642964 | UNKNOWN | Major Depressive Disorder (MDD) |
Chase Therapeutics Corporation |
2018-09-10 | PHASE2 |
| NCT07088601 | NOT_YET_RECRUITING | Post-Spinal Shivering |
Cairo University |
2025-08-10 | PHASE4 |
| NCT06656299 | RECRUITING | Cholecystitis; Cholecystitis, Acute; Cholecystitis, Chronic; Cholecystitis; Gallstone |
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital |
2024-10-30 | |
| NCT06080880 | RECRUITING | Nausea With Vomiting Chemotherapy-Induced |
Hubei Cancer Hospital |
2023-12-01 | |
| NCT07264738 | ACTIVE_NOT_RECRUITING | Esophagogastroduodensocopy (EGD) Procedure |
Peking Union Medical College Hospital |
2025-07-01 | PHASE4 |
| NCT07498751 | COMPLETED | Postoperative Nausea and Vomiting |
Luxena Pharmaceuticals, Inc. |
2025-03-13 | PHASE1 |
| NCT06297499 | RECRUITING | Pruritus Caused by Drug |
Wayne State University |
2024-08-22 | PHASE1 |
| NCT05035407 | TERMINATED | Kita-kyushu Lung Cancer Antigen 1, Human |
National Cancer Institute (NCI) |
2022-03-08 | PHASE1 |
| NCT02858310 | COMPLETED | Papillomavirus Infections; Cervical Intraepithelial Neoplasia; Carcinoma In Situ; Vulvar Neoplasms; Vulvar Diseases |
National Cancer Institute (NCI) |
2017-01-27 | PHASE1; PHASE2 |
| NCT06850740 | ENROLLING_BY_INVITATION | Hernia, Inguinal |
Suez Canal University |
2025-03-15 | |
| NCT06886230 | COMPLETED | Postoperative Nausea and Vomiting (PONV) |
Hafiz Muhammad Hamza |
2025-03-20 | PHASE4 |
| NCT05876585 | NOT_YET_RECRUITING | Gastroenteritis |
Genuine Research Center, Egypt |
2025-06-01 | PHASE3 |
| NCT07310563 | COMPLETED | Overweight; Obesity |
Amgen |
2024-12-10 | PHASE1 |
| NCT04226170 | TERMINATED | Myasthenia Gravis |
DAS-MG, Inc |
2023-11-08 | PHASE2 |
| NCT07087925 | COMPLETED | Postoperative Nausea and Vomiting (PONV); Subarachnoid Block; Spinal Anesthesia |
Rully Riyandika |
2025-01-15 | |
| NCT04606264 | COMPLETED | Perioperative Optimization |
Jennifer Holder-Murray |
2023-05-15 | PHASE3 |
| NCT06795594 | COMPLETED | Acupuncture Analgesia |
Beijing Tongren Hospital |
2025-01-05 | |
| NCT06930456 | ENROLLING_BY_INVITATION | Post Spinal Anaesthesia Hypotension |
Nada kamel Elgamal |
2024-03-01 | |
| NCT05620641 | COMPLETED | Post Operative Nausea and Vomiting; Sleeve Gastrectomy; Morbid Obesity |
Tanta University |
2022-10-01 | PHASE3 |
| NCT05872893 | COMPLETED | Pediatric Cancer |
Immune Oncology Research Institute |
2023-06-27 | PHASE3 |
| NCT06423820 | COMPLETED | Ondansetron Lozenge; Postoperative Nausea and Vomiting; Pediatrics; Squint |
Tanta University |
2024-05-21 | |
| NCT04169828 | COMPLETED | Juvenile Idiopathic Arthritis |
University of British Columbia |
2019-08-02 | |
| NCT05317611 | COMPLETED | Prevention |
Zagazig University |
2022-07-01 | |
| NCT06898268 | COMPLETED | Gastroesophageal Reflux Disorder |
Muhammad Aamir Latif |
2024-07-01 | |
| NCT06371014 | UNKNOWN | To Analyze and Compare the Efficacy and Safety of Ondansetron and Tablet for the Prevention of Moderate and Hypoemetic Chemotherapy |
Shanghai Children's Medical Center |
2024-05-01 | |
| NCT06437236 | UNKNOWN | Hemodynamic Instability and Shivering |
Sohag University |
2024-04-10 | |
| NCT06697782 | COMPLETED | Thyroid Cancer |
The First Affiliated Hospital of Zhengzhou University |
2024-07-01 | PHASE4 |
| NCT06153602 | COMPLETED | Transurethral Resection of Prostate |
Chulalongkorn University |
2023-12-07 | |
| NCT06475846 | COMPLETED | Preventing of Postoperative Nausea and Vomiting in Adults |
Fujian Shengdi Pharmaceutical Co., Ltd. |
2024-06-25 | PHASE2 |
| NCT06254131 | COMPLETED | Ondansetron Lozenge; Postoperative Nausea and Vomiting; Caesarean Section |
Tanta University |
2024-02-10 | |
| NCT06423807 | COMPLETED | Ondansetron Lozenge; Post-Spinal Shivering; Cesarean Section |
Tanta University |
2024-05-21 | |
| NCT04167813 | UNKNOWN | Parkinson's Hallucinations; Dementia With Lewy Bodies |
University College, London |
2021-10-01 | PHASE2 |
| NCT06300346 | UNKNOWN | Emetic Attacks During Caesarean Delivery With Spinal Anesthesia |
Sohag University |
2024-03-01 | |
| NCT04144933 | UNKNOWN | Anesthesia; General Anesthesia; Analgesics, Opioid; Opioid Free Anesthesia; Postoperative Ileus; Colorectal Surgery; Laparoscopic Surgery; Analgesia; Dexmedetomidine; Lidocaine; Ketamine |
University of Saskatchewan |
2021-05-15 | PHASE3 |
| NCT04817189 | COMPLETED | Chemotherapy-induced Nausea and Vomiting |
Helsinn Healthcare SA |
2021-02-01 | PHASE4 |
| NCT06444737 | UNKNOWN | Post-Dural Puncture Headache |
Mongi Slim Hospital |
2023-11-30 | |
| NCT03851835 | COMPLETED | Acute Gastroenteritis; Viral Illness; Vomiting; Diarrhea |
University of Calgary |
2019-09-14 | PHASE3 |
| NCT00001337 | COMPLETED | Diffuse Large B-Cell Lymphoma (DLBCL); Primary Mediastinal Large B-cell Lymphoma; Burkitt Lymphoma; Anaplastic Large-Cell Lymphoma; Gray Zone Lymphoma |
National Cancer Institute (NCI) |
1993-05-08 | PHASE2 |
| NCT05692245 | COMPLETED | Nausea and Vomiting, Postoperative; Cesarean Section Complications |
Beth Israel Deaconess Medical Center |
2023-03-30 | PHASE4 |
| NCT06390787 | COMPLETED | Vomiting |
University of Baghdad |
2024-01-30 | PHASE2; PHASE3 |
| NCT05819619 | TERMINATED | Nausea; Pain |
Hackensack Meridian Health |
2023-07-20 | EARLY_PHASE1 |
| NCT05956899 | COMPLETED | Idiopathic Scoliosis; Postoperative Nausea and Vomiting |
University of Malaya |
2023-06-01 | PHASE4 |
| NCT05514483 | UNKNOWN | Acute Respiratory Distress Syndrome |
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal |
2022-11-10 | PHASE4 |
| NCT06282211 | UNKNOWN | Nausea and Vomiting |
The First Affiliated Hospital of Xinxiang Medical College |
2024-02-20 | PHASE3 |
| NCT05346731 | UNKNOWN | Chemotherapy-induced Nausea and Vomiting |
Federal Research Institute of Pediatric Hematology, Oncology and Immunology |
2022-04-01 | PHASE3 |
| NCT06428084 | COMPLETED | Laparoscopic Cholecystectomy |
Universitas Padjadjaran |
2023-11-01 | PHASE2 |
| NCT05759481 | Recruiting | Post-operative Nausea and Vomiting |
Milton S. Hershey Medical Center |
2024-02-01 | Phase 2 |
| NCT04503668 | TERMINATED | Gynecologic Cancer |
University of Michigan Rogel Cancer Center |
2020-12-28 | PHASE3 |
| NCT05244577 | UNKNOWN | Olanzapine; CINV; Testicular Cancer by AJCC V6 and V7 Stage; Cisplatin |
Shi Yanxia |
2022-01-18 | PHASE3 |
| NCT05065567 | TERMINATED | Cyclic Vomiting Syndrome |
Corewell Health South |
2021-08-30 | PHASE3 |
| NCT04499274 | UNKNOWN | Blood Coagulation Disorder |
Seoul National University Bundang Hospital |
2020-09-16 | |
| NCT06175806 | COMPLETED | Nausea and Vomiting in Pediatric Age Group |
Ain Shams University |
2023-09-10 | |
| NCT05475873 | COMPLETED | Adverse Effect |
General Hospital of Ningxia Medical University |
2023-06-18 | |
| NCT04603066 | COMPLETED | Neuropathic Pain |
Washington University School of Medicine |
2021-01-31 | PHASE1; PHASE2 |
| NCT03030417 | COMPLETED | Solid Tumors; Lymphoma |
National Cancer Institute (NCI) |
2017-02-27 | PHASE1 |
| NCT06017167 | UNKNOWN | Postoperative Nausea and Vomiting; Laparoscopic Cholecystectomy |
Tanta University |
2022-09-15 | PHASE2 |
| NCT05378113 | TERMINATED | Injection Site Irritation |
Emory University |
2023-05-18 | PHASE2 |
| NCT05439772 | COMPLETED | Abdominal Pain; Inflammatory Bowel Diseases; Eosinophilic Gastroenteritis; Diarrhea; Hematochezia; Weight Loss |
State University of New York - Downstate Medical Center |
2021-01-01 | PHASE4 |
| NCT04508400 | COMPLETED | Pediatric Cancer |
Sun Yat-sen University |
2022-08-01 | PHASE2 |
| NCT05881486 | UNKNOWN | Postoperative Nausea and Vomiting; Anesthesia Complication; Thoracic Diseases |
Qilu Hospital of Shandong University |
2023-06 | |
| NCT05006638 | UNKNOWN | Pesticide Poisoning |
Aya Sabry Mohamed Mohamed |
2022-12 | PHASE4 |
| NCT05402553 | UNKNOWN | Sepsis; Septic Shock |
Noha Mansour |
2022-04-24 | PHASE1; PHASE2 |
| NCT05265507 | UNKNOWN | Postoperative Nausea and Vomiting |
The Second Affiliated Hospital of Chongqing Medical University |
2022-03-21 | PHASE4 |
| NCT04764344 | COMPLETED | Vomiting; Nausea; Abdominal Pain; Cannabis Use |
Western Michigan University School of Medicine |
2021-04-01 | PHASE4 |
| NCT05439798 | UNKNOWN | Laparoscopic Surgery; Pediatrics; Nausea and Vomiting, Postoperative; Antiemetics; Therapeutic Use |
Selcuk University |
2022-06-01 | PHASE3 |
| NCT04318847 | UNKNOWN | Vomiting in Infants and/or Children |
Lizar Aguirre Pascasio |
2021-10-10 | PHASE4 |
| NCT03125811 | COMPLETED | Nausea; Vomiting |
Texas Tech University Health Sciences Center, El Paso |
2017-07-17 | EARLY_PHASE1 |
| NCT04654429 | UNKNOWN | Temperature Change, Body; Chills; Tremor; Nausea, Postoperative; Vomiting, Postoperative; Postoperative Shivering |
Dr Lim Siu Min |
2020-10-13 | PHASE4 |
| NCT04785118 | COMPLETED | Vomiting |
Assiut University |
2021-10-01 | PHASE4 |
| NCT05590936 | COMPLETED | PONV in Laparoscopic Cholocystectomies |
University of Thessaly |
2018-01-01 | |
| NCT05583214 | UNKNOWN | Caesarean Section; Spinal Anesthesia |
Muhammad Mubariz |
2022-10 | PHASE4 |
| NCT05098067 | COMPLETED | Hyperemesis Gravidarum; Nausea Gravidarum; Vomiting of Pregnancy |
Women and Infants Hospital of Rhode Island |
2022-05-24 | PHASE2 |
| NCT03785691 | TERMINATED | Hyperemesis Gravidarum; Nausea Gravidarum; Vomiting of Pregnancy |
Nordsjaellands Hospital |
2019-03-01 | PHASE2 |
| NCT05342818 | COMPLETED | Delayed Gastric Emptying |
Tanta University |
2022-04-15 | PHASE2 |
| NCT03239210 | COMPLETED | Obsessive-Compulsive Disorder; Tic Disorders; Tourette Syndrome |
NYU Langone Health |
2017-06-16 | PHASE4 |
| NCT02991456 | COMPLETED | Chemo-radiation Induced Nausea and Vomiting |
Duke University |
2017-10-09 | PHASE2 |
| NCT05221151 | COMPLETED | Anxiety |
Menoufia University |
2022-01-30 | PHASE4 |
| NCT05137288 | UNKNOWN | Perineal Surgery |
Sohag University |
2021-12-01 | |
| NCT03931863 | UNKNOWN | Hypotension |
Aretaieion University Hospital |
2019-05-22 | PHASE3 |
| NCT04891484 | COMPLETED | Percutaneous Nephrolithotomy |
Mansoura University |
2021-04-01 | EARLY_PHASE1 |
| NCT04557189 | COMPLETED | Postoperative Nausea and Vomiting (PONV) |
Takeda |
2020-10-20 | PHASE2 |
| NCT05127876 | COMPLETED | Spinal Induced Hypotension |
Ain Shams University |
2022-01-10 | PHASE4 |
| NCT04101227 | COMPLETED | Alcohol Use Disorder |
Adial Pharmaceuticals |
2020-02-01 | PHASE3 |
| NCT05202574 | UNKNOWN | Post-Dural Puncture Headache |
Minia University |
2021-09-01 | PHASE2 |
| NCT05124067 | COMPLETED | Postoperative Nausea and Vomiting; Post Operative Pain; Emergence Delirium |
Tanta University |
2021-10-27 | PHASE1 |
| NCT04682743 | COMPLETED | Post-Operative Shivering |
Cairo University |
2021-01-06 | EARLY_PHASE1 |
| NCT04983498 | WITHDRAWN | Enhanced Recovery Pathway; Endoscopy |
Northwestern University |
2021-09-01 | PHASE4 |
| NCT00324467 | UNKNOWN | Lymphoma, Non-Hodgkin; Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma |
British Columbia Cancer Agency |
2006-08 | PHASE2 |
| NCT03182179 | COMPLETED | Rectal Cancer |
Ente Ospedaliero Cantonale, Bellinzona |
2016-11-01 | |
| NCT06927817 | COMPLETED | Cholecystitis; Pain; Nausea |
Saglik Bilimleri Universitesi |
2020-11-15 | PHASE4 |
| NCT03578081 | COMPLETED | Malignant Neoplasm |
Alliance for Clinical Trials in Oncology |
2018-11-20 | PHASE3 |
| NCT04461093 | COMPLETED | Palonosetron |
Mohd Zulfakar Mazlan, MBBS |
2020-07-06 | |
| NCT04509258 | UNKNOWN | the Study Focus to Improve the Standard of Care Used for Aluminuim Phosphide Poisoning and to Save Patients With the Minimal Organ Damage |
Cairo University |
2020-10 | PHASE4 |
| NCT06289335 | COMPLETED | Postanesthetic Excitement; Cesarean Section |
Hospital Central "Dr. Ignacio Morones Prieto" |
2020-08-05 | PHASE2 |
| NCT05087615 | COMPLETED | Bariatric Surgery Candidate; Perioperative Complication; Nausea; Vomiting, Postoperative; Drug Effect |
Shahid Beheshti University of Medical Sciences |
2021-03-01 | PHASE3 |
| NCT04209595 | COMPLETED | Small Cell Lung Cancer; Extra-Pulmonary Small Cell Carcinomas |
National Cancer Institute (NCI) |
2020-04-08 | PHASE1; PHASE2 |
| NCT04703088 | UNKNOWN | Hypotension; Anesthesia; Adverse Effect, Spinal and Epidural; Cesarean Section |
Laval University |
2021-06 | PHASE3 |
| NCT05076461 | COMPLETED | Vomiting in Infants and/or Children; Acute Gastroenteritis |
Tehsil Headquarter Hospital |
2020-07-01 | |
| NCT04745273 | COMPLETED | Cholecystectomy, Laparoscopic |
Acibadem University |
2020-09-02 | PHASE4 |
| NCT04870541 | UNKNOWN | Shivering; Adverse Effects in the Therapeutic Use of Anaesthetic |
Saint-Joseph University |
2020-12-01 | PHASE4 |
| NCT04576390 | UNKNOWN | Antiemetic; Postoperative Nausea and Vomiting |
Theodor Bilharz Research Institute |
2020-10-24 | PHASE4 |
| NCT03593811 | COMPLETED | Nausea |
Vanderbilt University Medical Center |
2018-08-03 | EARLY_PHASE1 |
| NCT03079219 | COMPLETED | Breast Cancer |
CCTU |
2017-03-23 | PHASE3 |
| NCT03237611 | TERMINATED | Chemotherapy-induced Nausea and Vomiting |
Albert Einstein College of Medicine |
2018-10-30 | PHASE2 |
| NCT04468685 | COMPLETED | Cholecystitis |
National Hepatology & Tropical Medicine Research Institute |
2020-07-15 | PHASE2 |
| NCT03809234 | TERMINATED | Neuropathic Pain |
Washington University School of Medicine |
2019-05-20 | PHASE1 |
| NCT03117894 | COMPLETED | Breast Neoplasm Female; Regional Anesthesia; Anesthesia; Regional Anesthesia Morbidity; Anesthesia Morbidity |
Umeå University |
2017-05-23 | |
| NCT01965704 | COMPLETED | Narcotic Addiction; Neonatal Abstinence Syndrome |
Stanford University |
2014-09-09 | PHASE2 |
| NCT03052361 | TERMINATED | Gastroenteritis |
St. Justine's Hospital |
2017-07-15 | PHASE2; PHASE3 |
| NCT04294992 | UNKNOWN | Spinal Anaesthetic |
Kasr El Aini Hospital |
2020-04-01 | |
| NCT03555188 | COMPLETED | IBS - Irritable Bowel Syndrome |
University of Leeds |
2018-03-29 | PHASE3 |
| NCT03876938 | UNKNOWN | Antiemetic for Highly Emetogenic Chemotherapy |
Mahidol University |
2019-03-01 | PHASE3 |
| NCT02732015 | TERMINATED | Locally Advanced Sarcoma |
M.D. Anderson Cancer Center |
2016-10-12 | PHASE2 |
| NCT07334223 | COMPLETED | Postoperative Shivering; Postspinal Shivering |
Mayo Hospital Lahore |
2020-01-01 | |
| NCT03023462 | COMPLETED | Inguinal Hernia; Pain, Postoperative |
Ostfold Hospital Trust |
2019-09-05 | |
| NCT02354703 | COMPLETED | Alcohol Use Disorder |
University of Maryland, Baltimore |
2015-08 | PHASE2 |
| NCT04191694 | UNKNOWN | PONV |
Coombe Women and Infants University Hospital |
2019-10-28 | |
| NCT03973411 | UNKNOWN | Hypotension |
Hospital de Base |
2019-03-01 | PHASE4 |
| NCT03503292 | COMPLETED | Postoperative Nausea |
Mayo Clinic |
2018-05-02 | PHASE4 |
| NCT04613726 | COMPLETED | Vomiting, Postoperative; Postoperative Complications; Hypotension |
Ataturk University |
2018-12-03 | PHASE3 |
| NCT03603119 | COMPLETED | Postoperative Nausea and Vomiting |
Institute of Liver and Biliary Sciences, India |
2018-05-01 | |
| NCT01536392 | COMPLETED | Cancer of the Cervix |
M.D. Anderson Cancer Center |
2012-03 | PHASE3 |
| NCT03859102 | UNKNOWN | Cardiac Surgery; Coronary Artery Disease; Aortic Valve Disease; Mitral Valve Disease; Tricuspid Valve Disease; Aortic Root Dilatation |
James Cook University Hospital |
2018-12-17 | |
| NCT02987985 | COMPLETED | Anesthesia; General Anesthesia; Analgesics, Opioid; Postoperative Complications; Pathologic Processes; Physiologic Effects of Drugs; Narcotics; Analgesics; Sleep Disordered Breathing; Obstructive Sleep Apnea of Child; Tonsillectomy; Respiratory Depression; Dexmedetomidine; Ketamine; Lidocaine; Gabapentin; Pulse Oximetry |
University of Saskatchewan |
2017-10-15 | PHASE3 |
| NCT02601027 | COMPLETED | Breast - Female |
Stanford University |
2015-11 | PHASE3 |
| NCT07068230 | COMPLETED | Postdural Puncture Headache; Postoperative Nausea and Vomiting; Obstetric Anesthesia Problems |
Minia University |
2018-10-01 | PHASE4 |
| NCT03022240 | COMPLETED | Cognitive Change; Behavior |
University of Calgary |
2017-01 | PHASE3 |
| NCT03262038 | TERMINATED | Pruritus; Nausea/Vomiting |
University of Michigan |
2017-12-07 | PHASE4 |
| NCT03459248 | COMPLETED | Postoperative Nausea and Vomiting |
Makassed General Hospital |
2018-02-15 | |
| NCT03219710 | COMPLETED | Chemotherapy-induced Nausea and Vomiting |
All India Institute of Medical Sciences |
2017-07-01 | PHASE3 |
| NCT03056482 | COMPLETED | Cannabis Use Disorder |
Dr. Marco L.A. Sivilotti |
2017-05-21 | PHASE4 |
| NCT03833999 | COMPLETED | Motility Disorder of Intestine; Ondansetron; Small Bowel Water |
University of Nottingham |
2018-10-16 | PHASE4 |
| NCT03478605 | UNKNOWN | Emesis; Vomiting; Nausea Post Chemotherapy; Nausea; Chemotherapy-induced Nausea and Vomiting |
Blokhin's Russian Cancer Research Center |
2018-05-25 | PHASE2 |
| NCT03297021 | COMPLETED | Post-operative Nausea and Vomiting |
Icahn School of Medicine at Mount Sinai |
2017-10-23 | PHASE4 |
| NCT02456662 | COMPLETED | Drug-induced Nausea and Vomiting |
University of Rochester |
2015-10-07 | |
| NCT03435003 | COMPLETED | Post-operative Nausea and Vomiting; Laparoscopic Sleeve Gastrectomy |
Stony Brook University |
2017-08-28 | PHASE4 |
| NCT02618343 | COMPLETED | Nausea |
The University of Texas Health Science Center at San Antonio |
2016-10-04 | |
| NCT03747341 | COMPLETED | Healthy; Opioid Use |
Indivior Inc. |
2018-03-22 | PHASE1 |
| NCT03041935 | COMPLETED | Testicle Undescended; Pain, Postoperative |
Alberta Children's Hospital |
2015-09-01 | |
| NCT03141645 | COMPLETED | Postoperative Nausea; Postoperative Vomiting; Postoperative Nausea and Vomiting |
Siriraj Hospital |
2017-06-20 | |
| NCT03035942 | COMPLETED | Fractures, Bone; Nausea and Vomiting, Postoperative; Pruritus; Morphine Adverse Reaction; Satisfaction, Personal |
Pontificia Universidade Catolica de Sao Paulo |
2017-01-02 | PHASE4 |
| NCT03041948 | UNKNOWN | Hernia, Inguinal; Pain, Postoperative |
Alberta Children's Hospital |
2015-09-01 | |
| NCT02724033 | TERMINATED | Anesthesia, Pediatrics, Surgery |
Indiana University |
2014-05 | PHASE4 |
| NCT03530007 | UNKNOWN | Shivering; Ondansetron |
Assiut University |
2018-05-15 | PHASE2; PHASE3 |
| NCT03583489 | COMPLETED | Postoperative Nausea and Vomiting |
Acacia Pharma Ltd |
2018-07-17 | PHASE1 |
| NCT01121042 | COMPLETED | Schizoaffective and Schizophreniform Disorders; Schizophrenia |
Bayside Health |
2010-07 | PHASE3 |
| NCT02966041 | COMPLETED | Postoperative Nausea and Vomiting |
University of British Columbia |
2018-03-06 | |
| NCT03606369 | UNKNOWN | Breast Neoplasm; Antineoplastic Agents; Antiemetics; Quality of Life |
Instituto Nacional de Cancerologia de Mexico |
2015-11-05 | PHASE2; PHASE3 |
| NCT02979548 | UNKNOWN | Chemotherapy Induced Vomiting; Acute Myeloid Leukemia |
Dr Atul Sharma |
2016-11 | PHASE3 |
| NCT03152955 | UNKNOWN | Trigeminal Neuralgia |
Xiangya Hospital of Central South University |
2017-05-15 | PHASE4 |
| NCT02082678 | COMPLETED | Bipolar Disorder; Alcohol Use Disorder; Dual Diagnosis |
University of Texas Southwestern Medical Center |
2014-02 | PHASE4 |
| NCT03421860 | COMPLETED | Cardiac Output, Low |
University Tunis El Manar |
2017-02-23 | PHASE4 |
| NCT02635984 | COMPLETED | Complications of Bone Marrow Transplant; Hematologic Neoplasms |
Augusta University |
2015-11 | PHASE3 |
| NCT01870648 | COMPLETED | Dehydration; Gastroenteritis; Vomiting; Diarrhea |
Dr. Stephen Freedman |
2014-05 | PHASE4 |
| NCT01591291 | WITHDRAWN | Alcoholism |
University of Virginia |
2012-06 | PHASE2; PHASE3 |
| NCT03629522 | COMPLETED | Ondansetron; Cesarean Section; Spinal Anesthesia; Hemodynamics |
University Hospital, Mahdia |
2017-08-01 | PHASE4 |
| NCT03653520 | COMPLETED | Cataract |
Avanti Anesthesia |
2017-06-28 | |
| NCT02625181 | COMPLETED | Postoperative Nausea and Vomiting |
Vanderbilt University |
2016-07 | |
| NCT02760069 | COMPLETED | Nausea |
Brooke Army Medical Center |
2016-01 | PHASE4 |
| NCT02913768 | COMPLETED | Hypotension |
Assiut University |
2016-10 | PHASE4 |
| NCT02928601 | COMPLETED | Maternal Hypotension |
Cukurova University |
2016-11 | PHASE4 |
| NCT01913990 | UNKNOWN | Emesis |
Ottawa Hospital Research Institute |
2011-09 | PHASE4 |
| NCT01661335 | COMPLETED | Nausea; Vomiting; Childhood Cancer |
University of Oklahoma |
2012-06-01 | PHASE3 |
| NCT02757105 | COMPLETED | Irritable Bowel Syndrome With Diarrhea |
RedHill Biopharma Limited |
2016-05-19 | PHASE2 |
| NCT02793843 | COMPLETED | Pruritus; Cesarean Section |
Makassed General Hospital |
2016-06 | |
| NCT01450826 | COMPLETED | Nausea; Vomiting; Glioma |
Katy Peters |
2014-06-24 | PHASE2 |
| NCT03075163 | TERMINATED | Vomiting; Nausea |
University of California, Davis |
2016-10-18 | PHASE4 |
| NCT02657031 | COMPLETED | Headache |
University Medical Center of Southern Nevada |
2016-03-17 | PHASE4 |
| NCT02519842 | TERMINATED | Chemotherapy-induced Nausea and Vomiting |
Merck Sharp & Dohme LLC |
2015-09-14 | PHASE3 |
| NCT02246439 | COMPLETED | Gastroenteritis; Gastritis |
RedHill Biopharma Limited |
2014-12-08 | PHASE3 |
| NCT02460341 | COMPLETED | Brain Function; Healthy Adults |
Icahn School of Medicine at Mount Sinai |
2015-08 | PHASE1 |
| NCT02468323 | COMPLETED | PONV |
Hospital de Base |
2015-10 | PHASE4 |
| NCT01870635 | COMPLETED | Dehydration; Gastroenteritis; Vomiting; Diarrhea |
Dr. Stephen Freedman |
2014-05 | PHASE4 |
| NCT04140058 | COMPLETED | Hypotension; Nausea; Vomiting |
University of Jordan |
2016-01-02 | PHASE3 |
| NCT02541019 | COMPLETED | Postoperative Nausea and Vomiting |
Hospital Federal de Bonsucesso |
2015-10 | PHASE4 |
| NCT01254877 | COMPLETED | Alcohol Abuse; Alcohol Dependence |
Johns Hopkins University |
2010-12 | PHASE2 |
| NCT01697579 | COMPLETED | Chemotherapy-induced Nausea and Vomiting |
Merck Sharp & Dohme LLC |
2012-12-13 | PHASE2 |
| NCT02901054 | COMPLETED | Pain |
Washington University School of Medicine |
2016-08-25 | |
| NCT02985840 | TERMINATED | Nausea; Abdominal Pain |
OhioHealth |
2014-01-28 | PHASE4 |
| NCT02953210 | UNKNOWN | Pain, Postoperative; Anesthesia Complication; Nausea; Vomiting; Ileus Paralytic; Hemodynamic Instability |
Federal University of São Paulo |
2016-11 | PHASE4 |
| NCT02652312 | COMPLETED | Anesthesia |
Theodor Bilharz Research Institute |
2016-02 | |
| NCT02883192 | UNKNOWN | Adverse Anesthesia Outcome |
Bnai Zion Medical Center |
2016-02 | |
| NCT01732458 | COMPLETED | Post-operative Nausea; Post-operative Vomiting |
Merck Sharp & Dohme LLC |
2013-02-12 | PHASE2 |
| NCT00890149 | TERMINATED | Alcohol Abuse; Alcoholism |
University of Maryland, Baltimore |
2015-09 | PHASE2 |
| NCT03134612 | COMPLETED | General Anesthesia With Propofol |
Indonesia University |
2016-07 | PHASE2 |
| NCT00970905 | COMPLETED | Nausea; Vomiting |
University of Vermont |
2009-10 | PHASE2 |
| NCT02803788 | UNKNOWN | Postoperative Nausea and Vomiting |
Government Medical College, Haldwani |
2015-07 | PHASE4 |
| NCT02460055 | WITHDRAWN | Dysphagia; Respiratory Complications |
Baylor College of Medicine |
2016-03 | |
| NCT02619201 | UNKNOWN | Acute Gastroenteritis; Vomiting |
Hospital General Naval de Alta Especialidad - Escuela Medico Naval |
2015-11 | PHASE3 |
| NCT03017222 | COMPLETED | Abdominal Mass |
Yonsei University |
2015-09-07 | |
| NCT02614586 | TERMINATED | Schizophrenia |
Takeda |
2015-12 | PHASE1 |
| NCT01370408 | COMPLETED | Chemotherapy-induced Nausea and Vomiting |
Northside Hospital, Inc. |
2012-02 | PHASE2 |
| NCT02959840 | COMPLETED | Nausea; Vomiting; Satisfaction |
Rutgers, The State University of New Jersey |
2015-07 | PHASE4 |
| NCT03685032 | COMPLETED | Microvascular Decompression Surgery; Postoperative Nausea and Vomiting |
Khon Kaen University |
2014-08-07 | |
| NCT02327923 | COMPLETED | Gall Stone Disease |
B.P. Koirala Institute of Health Sciences |
2015-01 | PHASE4 |
| NCT02441894 | COMPLETED | Prostate Cancer |
Sanofi |
2015-04 | PHASE4 |
| NCT01691690 | COMPLETED | Adenotonsillitis; Tonsillitis |
Nationwide Children's Hospital |
2012-10 | PHASE2 |
| NCT02085577 | COMPLETED | Postoperative Pain; Chronic Pain; Analgesics |
Rigshospitalet, Denmark |
2014-05 | PHASE4 |
| NCT01275248 | TERMINATED | Obsessive-compulsive Disorder |
Transcept Pharmaceuticals |
2011-01 | PHASE2 |
| NCT02386059 | UNKNOWN | Postoperative Nausea and Vomiting |
University of Catania |
2015-03 | PHASE4 |
| NCT02357693 | COMPLETED | Postoperative Nausea and Vomiting |
Instituto do Cancer do Estado de São Paulo |
2015-02 | PHASE4 |
| NCT02408146 | UNKNOWN | Pain, Postoperative |
First Affiliated Hospital of Harbin Medical University |
2014-01 | |
| NCT02862873 | TERMINATED | Hypotension |
Centre Hospitalier Universitaire Dijon |
2015-03 | |
| NCT02106494 | COMPLETED | Chemotherapy-induced Nausea and Vomiting |
Heron Therapeutics |
2014-03 | PHASE3 |
| NCT02116530 | COMPLETED | Hematopoietic/Lymphoid Cancer; Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific |
Alliance for Clinical Trials in Oncology |
2014-08-20 | PHASE3 |
| NCT01549652 | COMPLETED | Opioid Withdrawal; Physical Dependence |
Stanford University |
2011-04 | |
| NCT02194192 | COMPLETED | Anesthesia; Adverse Effect, Spinal and Epidural |
Mahidol University |
2014-07 | |
| NCT02234466 | UNKNOWN | Breast Cancer |
University of Manitoba |
2014-08 | PHASE2 |
| NCT02830906 | COMPLETED | Postoperative Nausea and Vomiting |
Thammasat University |
2014-04 | PHASE3 |
| NCT01857232 | COMPLETED | CINV |
Acacia Pharma Ltd |
2013-10 | PHASE2 |
| NCT02473887 | COMPLETED | Gastroenteritis |
Hamad Medical Corporation |
2014-09 | PHASE1 |
| NCT02382146 | COMPLETED | Postoperative Nausea and Vomiting |
Yeditepe University Hospital |
2012-04 | PHASE4 |
| NCT02026778 | COMPLETED | Nausea and Vomiting |
Yonsei University |
2013-12 | |
| NCT01594749 | COMPLETED | Chemotherapy-Induced Nausea and Vomiting (CINV) |
Merck Sharp & Dohme LLC |
2012-09-24 | PHASE3 |
| NCT01393288 | WITHDRAWN | Postoperative Nausea and Vomiting; Genetic Polymorphisms |
University of California, San Francisco |
2013-11 | |
| NCT02296333 | COMPLETED | Postoperative Pain |
Mustafa Kemal University |
2014-05 | PHASE4 |
| NCT02028910 | TERMINATED | Vomiting; Gastroenteritis |
Assistance Publique - Hôpitaux de Paris |
2014-01 | PHASE3 |
| NCT01851993 | COMPLETED | Dyspnea |
McGill University |
2013-06 | EARLY_PHASE1 |
| NCT01952886 | WITHDRAWN | Malignant Glioma |
Duke University |
PHASE2 | |
| NCT01912807 | COMPLETED | Postoperative Vomiting |
University of Saskatchewan |
2013-12 | |
| NCT01636947 | COMPLETED | Nausea; Vomiting |
Merck Sharp & Dohme LLC |
2012-12-12 | PHASE4 |
| NCT03435692 | TERMINATED | Hip Surgery; Post Operative Pain Control |
Seattle Children's Hospital |
2011-07-15 | |
| NCT02006056 | COMPLETED | Nausea; Vomiting |
Sunnybrook Health Sciences Centre |
2013-11 | PHASE2 |
| NCT02410460 | COMPLETED | Rhytidoplasty |
Mercy Facial Plastic Surgery Center |
2013-09 | |
| NCT01952626 | COMPLETED | Morphine Adverse Reaction |
Kyungpook National University Hospital |
2013-04 | |
| NCT01815125 | COMPLETED | Traumatic Brain Injury; Brain Concussion |
St. Justine's Hospital |
2013-03 | PHASE1 |
| NCT00818259 | TERMINATED | Chemotherapy-Induced Nausea and Vomiting |
Merck Sharp & Dohme LLC |
2009-02-05 | PHASE1 |
| NCT01876290 | COMPLETED | Postoperative Nausea and Vomiting |
Hopital Foch |
2013-05 | PHASE4 |
| NCT00689572 | COMPLETED | Cocaine Dependence |
University of Virginia |
2008-07 | PHASE2 |
| NCT00757822 | COMPLETED | Postoperative Nausea and Vomiting |
VA Office of Research and Development |
2009-12 | |
| NCT01841606 | COMPLETED | Cardiac Output |
University of British Columbia |
2013-03 | PHASE2 |
| NCT01257672 | COMPLETED | Gastroenteritis; Vomiting; Acute Gastroenteritis |
IRCCS Burlo Garofolo |
2011-07 | PHASE3 |
| NCT01572012 | COMPLETED | Healthy |
Halozyme Therapeutics |
2012-02 | PHASE1 |
| NCT01896440 | WITHDRAWN | Malignant Childhood Neoplasm |
University of Oklahoma |
2013-10 | PHASE4 |
| NCT01819857 | COMPLETED | Cardiac Repolarization |
Medical University of Gdansk |
2011-06 | PHASE4 |
| NCT01739985 | COMPLETED | Postoperative Vomiting |
Assistance Publique - Hôpitaux de Paris |
2010-12 | |
| NCT01006707 | COMPLETED | Substance-Related Disorders |
Stanford University |
2010-11 | |
| NCT01897337 | COMPLETED | Postoperative Nausea and Vomiting |
Yonsei University |
2012-06 | PHASE4 |
| NCT02658721 | COMPLETED | Anesthesia |
Bagcilar Training and Research Hospital |
2013-01 | PHASE3 |
| NCT01602029 | COMPLETED | Schizophrenia; Schizoaffective Disorder; Psychosis Not Otherwise Specified; Schizophreniform Disorder |
Pakistan Institute of Living and Learning |
2010-08 | PHASE2 |
| NCT01434017 | COMPLETED | Postoperative Nausea and Vomiting |
Centre Hospitalier Universitaire Vaudois |
2008-11 | PHASE4 |
| NCT01837394 | COMPLETED | Postoperative Pain; Postoperative Nausea and Vomiting; Postoperative Function Level |
Jens Borglum Neimann |
2012-08 | PHASE4 |
| NCT00006205 | UNKNOWN | Alcoholism |
Bankole Johnson |
2005-03 | PHASE2 |
| NCT01801475 | COMPLETED | Postoperative Nausea |
Stanford University |
2013-01 | PHASE1; PHASE2 |
| NCT01377662 | COMPLETED | Methamphetamine Dependence; Cocaine Dependence |
Tong Lee |
2011-08 | PHASE2 |
| NCT00954941 | COMPLETED | Hematologic Diseases; Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Chronic Myelogenous Leukemia |
M.D. Anderson Cancer Center |
2009-11 | PHASE2 |
| NCT01362530 | COMPLETED | Chemotherapy Induced Nausea and Vomiting |
Merck Sharp & Dohme LLC |
2011-09-13 | PHASE3 |
| NCT00819039 | COMPLETED | Postoperative Nausea and Vomiting |
Merck Sharp & Dohme LLC |
2009-01-26 | PHASE1 |
| NCT01859715 | COMPLETED | Drug Interactions |
University of Colorado, Denver |
2012-06 | |
| NCT01759706 | COMPLETED | Pancreatic Neoplasms |
Università Vita-Salute San Raffaele |
2010-10 | |
| NCT01050270 | COMPLETED | Overdose |
University of Edinburgh |
2010-09 | PHASE4 |
| NCT01669213 | UNKNOWN | Hypotension; Shivering; Nausea and Vomiting; Vasopressor |
Seoul National University Hospital |
2012-08 | |
| NCT00768508 | COMPLETED | Alcoholism |
Bankole Johnson |
2008-09 | PHASE3 |
| NCT01474915 | COMPLETED | Postoperative Nausea and Vomiting (PONV); Nausea |
Sergio Bergese |
2007-06 | PHASE4 |
| NCT01536691 | UNKNOWN | Cancer; Malignancy |
Hallym University Medical Center |
2011-06 | PHASE3 |
| NCT01442376 | COMPLETED | Chemotherapy-Induced Nausea and Vomiting |
Helsinn Healthcare SA |
2011-09 | PHASE3 |
| NCT01668069 | COMPLETED | Vomiting of Pregnancy |
United States Naval Medical Center, San Diego |
2012-10 | |
| NCT01290276 | COMPLETED | Healthy |
Tong Lee |
2010-12 | PHASE1 |
| NCT01507194 | COMPLETED | Postoperative Nausea and Vomiting |
Accenture |
2012-02 | PHASE2 |
| NCT02143531 | COMPLETED | Postoperative Nausea and Vomiting |
American University of Beirut Medical Center |
2008-09 | PHASE4 |
| NCT02021851 | COMPLETED | Postoperative Nausea and Vomiting |
Yeditepe University Hospital |
2011-07 | PHASE4 |
| NCT01510379 | COMPLETED | Nausea and Vomiting Post-foregut Surgery |
Kyle A Perry |
2011-08 | |
| NCT01432977 | COMPLETED | Pain |
University Hospital, Limoges |
2011-09 | PHASE3 |
| NCT01477242 | UNKNOWN | Sedation and Analgesia; Side Effect of Drug |
Seoul National University Hospital |
2011-11 | |
| NCT01395901 | COMPLETED | Postoperative Nausea and Vomiting |
Helsinn Healthcare SA |
2011-06 | PHASE3 |
| NCT01113164 | COMPLETED | Alcoholism |
Brown University |
2008-09 | PHASE1 |
| NCT01067677 | WITHDRAWN | Post Operative Nausea and Vomiting; Rescue Emetic Therapy |
Franklyn Cladis |
2010-02 | |
| NCT01449188 | COMPLETED | Nausea and Vomiting, Chemotherapy-Induced |
GlaxoSmithKline |
2011-08-16 | PHASE1 |
| NCT01543945 | COMPLETED | Postoperative Nausea and Vomiting |
Prince of Songkla University |
2008-03 | PHASE2 |
| NCT01578252 | COMPLETED | Fasting State |
IPCA Laboratories Ltd. |
2011-05 | PHASE1 |
| NCT01578265 | COMPLETED | Fed |
IPCA Laboratories Ltd. |
2011-05 | PHASE1 |
| NCT00651755 | COMPLETED | Lymphoma |
M.D. Anderson Cancer Center |
2008-03 | |
| NCT01640340 | COMPLETED | Malignant Neoplasm |
Ohio State University Comprehensive Cancer Center |
2011-01 | |
| NCT00745004 | COMPLETED | Irritable Bowel Syndrome With Diarrhoea |
University of Nottingham |
2009-01 | PHASE4 |
| NCT01297010 | COMPLETED | Vomiting Postoperative |
Instituto Materno Infantil Prof. Fernando Figueira |
2011-03 | PHASE3 |
| NCT01414777 | COMPLETED | Hypotension; Pregnancy |
University of Virginia |
2009-11 | PHASE2; PHASE3 |
| NCT01169805 | COMPLETED | Laparoscopic Marsupialization of Renal Cyst |
Yonsei University |
2010-08 | |
| NCT00793663 | COMPLETED | Anaesthetics Gases, Xenon; Anaesthetics Volatile, Sevoflurane; Depth of Anaesthesia; Postoperative Nausea; Postoperative Vomiting |
RWTH Aachen University |
2008-11 | PHASE4 |
| NCT01216410 | COMPLETED | Cesarean Delivery |
Duke University |
2008-12 | |
| NCT00971399 | COMPLETED | Radiotherapy Induced Nausea and Vomiting |
Seoul National University Hospital |
2009-09 | PHASE3 |
| NCT01679093 | COMPLETED | Interaction Between Antiemetic Drugs and Paracetamol |
University Hospital, Lille |
2009-06 | PHASE3 |
| NCT00343863 | COMPLETED | Male Breast Cancer; Nausea and Vomiting; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer |
University of Washington |
2006-01 | |
| NCT00641797 | COMPLETED | Benign Paroxysmal Positional Vertigo |
Lehigh Valley Hospital |
2006-11 | |
| NCT00918190 | COMPLETED | Postoperative Nausea and Vomiting |
King Khaled Eye Specialist Hospital |
2009-06 | |
| NCT01111851 | COMPLETED | Chemotherapy-Induced Nausea and Vomiting (CINV) |
Merck Sharp & Dohme LLC |
2010-04 | PHASE1 |
| NCT00738621 | COMPLETED | Postoperative Nausea and Vomiting |
Scott and White Hospital & Clinic |
2008-07 | PHASE4 |
| NCT01007500 | COMPLETED | Nausea; Vomiting |
Yonsei University |
2009-09 | PHASE4 |
| NCT00599573 | UNKNOWN | HIV Infections; Cocaine Dependence |
University of Virginia |
2007-10 | |
| NCT00891761 | WITHDRAWN | Cancer; Chemotherapy-Induced Nausea and Vomiting; Nausea and Vomiting; Solid Tumor Cancer |
GlaxoSmithKline |
2009-09 | PHASE3 |
| NCT01093690 | COMPLETED | Cancer |
Mahidol University |
2009-04 | |
| NCT00149734 | COMPLETED | Schizophrenia |
University of Colorado, Denver |
2005-01 | PHASE3 |
| NCT00892996 | UNKNOWN | Pregnancy; PONV |
Mahidol University |
2009-05 | |
| NCT01303536 | COMPLETED | Obsessive Compulsive Disorder |
Institute of Neuroscience, Florence, Italy |
2009-12 | PHASE4 |
| NCT00871910 | COMPLETED | Solid Tumors; Lymphoma, Non-Hodgkin; Multiple Myeloma |
Merck Sharp & Dohme LLC |
2006-10-11 | PHASE1 |
| NCT00878228 | COMPLETED | Nausea and Vomiting, Postoperative |
Hospital for Special Surgery, New York |
2009-04 | PHASE4 |
| NCT00588835 | TERMINATED | Tumor |
Radboud University Medical Center |
2008-03 | PHASE4 |
| NCT00967499 | COMPLETED | Postoperative Nausea and Vomiting |
Eisai Inc. |
2009-07-13 | PHASE2 |
| NCT00659945 | COMPLETED | Postoperative Nausea and Vomiting |
University of Pittsburgh |
2008-06 | PHASE4 |
| NCT00929955 | COMPLETED | Schizophrenia; Schizoaffective Disorder; Psychosis Not Otherwise Specified; Schizophreniform Disorder |
Pakistan Institute of Living and Learning |
2009-06 | PHASE1 |
| NCT00691275 | WITHDRAWN | Dehydration; Gastroenteritis |
Children's Hospitals and Clinics of Minnesota |
2008-09 | |
| NCT01031498 | COMPLETED | Acute Myelogenous Leukemia; Chemotherapy-induced Nausea and Vomiting |
M.D. Anderson Cancer Center |
2005-09 | PHASE2 |
| NCT00429702 | TERMINATED | Nausea; Vomiting; Unspecified Childhood Solid Tumor, Protocol Specific |
University of South Florida |
2007-10 | PHASE2 |
| NCT00624208 | COMPLETED | Myocardial Repolarization |
University of British Columbia |
2008-02 | |
| NCT00695864 | COMPLETED | Substance Withdrawal Syndrome |
Stanford University |
2008-05 | |
| NCT00795769 | COMPLETED | Accelerated Phase Chronic Myelogenous Leukemia; Adult Acute Lymphoblastic Leukemia in Remission; Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Atypical Chronic Myeloid Leukemia, BCR-ABL Negative; Blastic Phase Chronic Myelogenous Leukemia; Chronic Eosinophilic Leukemia; Chronic Myelomonocytic Leukemia; Chronic Neutrophilic Leukemia; Chronic Phase Chronic Myelogenous Leukemia; de Novo Myelodysplastic Syndromes; Disseminated Neuroblastoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Nodal Marginal Zone B-cell Lymphoma; Noncontiguous Stage II Adult Burkitt Lymphoma; Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma; Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma; Noncontiguous Stage II Adult Lymphoblastic Lymphoma; Noncontiguous Stage II Grade 1 Follicular Lymphoma; Noncontiguous Stage II Grade 2 Follicular Lymphoma; Noncontiguous Stage II Grade 3 Follicular Lymphoma; Noncontiguous Stage II Mantle Cell Lymphoma; Noncontiguous Stage II Marginal Zone Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Poor Prognosis Metastatic Gestational Trophoblastic Tumor; Previously Treated Myelodysplastic Syndromes; Primary Myelofibrosis; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Childhood Large Cell Lymphoma; Recurrent Childhood Lymphoblastic Lymphoma; Recurrent Childhood Small Noncleaved Cell Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Malignant Testicular Germ Cell Tumor; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Neuroblastoma; Recurrent Ovarian Epithelial Cancer; Recurrent Ovarian Germ Cell Tumor; Recurrent Small Lymphocytic Lymphoma; Recurrent/Refractory Childhood Hodgkin Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Hairy Cell Leukemia; Relapsing Chronic Myelogenous Leukemia; Secondary Acute Myeloid Leukemia; Secondary Myelodysplastic Syndromes; Splenic Marginal Zone Lymphoma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage II Ovarian Epithelial Cancer; Stage III Adult Burkitt Lymphoma; Stage III Adult Diffuse Large Cell Lymphoma; Stage III Adult Diffuse Mixed Cell Lymphoma; Stage III Adult Diffuse Small Cleaved Cell Lymphoma; Stage III Adult Hodgkin Lymphoma; Stage III Adult Immunoblastic Large Cell Lymphoma; Stage III Adult Lymphoblastic Lymphoma; Stage III Chronic Lymphocytic Leukemia; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Stage III Grade 3 Follicular Lymphoma; Stage III Malignant Testicular Germ Cell Tumor; Stage III Mantle Cell Lymphoma; Stage III Marginal Zone Lymphoma; Stage III Multiple Myeloma; Stage III Ovarian Epithelial Cancer; Stage III Small Lymphocytic Lymphoma; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Adult Burkitt Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; Stage IV Adult Diffuse Mixed Cell Lymphoma; Stage IV Adult Diffuse Small Cleaved Cell Lymphoma; Stage IV Adult Hodgkin Lymphoma; Stage IV Adult Immunoblastic Large Cell Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Stage IV Breast Cancer; Stage IV Chronic Lymphocytic Leukemia; Stage IV Grade 1 Follicular Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Stage IV Grade 3 Follicular Lymphoma; Stage IV Mantle Cell Lymphoma; Stage IV Marginal Zone Lymphoma; Stage IV Ovarian Epithelial Cancer; Stage IV Small Lymphocytic Lymphoma |
Fred Hutchinson Cancer Center |
2008-08-08 | PHASE2 |
| NCT00619359 | COMPLETED | Chemotherapy-Induced Nausea and Vomiting (CINV) |
Merck Sharp & Dohme LLC |
2008-02 | PHASE3 |
| NCT00734929 | COMPLETED | Postoperative Nausea and Vomiting |
Duke University |
2007-09 | PHASE4 |
| NCT00601172 | COMPLETED | Nausea and Vomiting, Chemotherapy-Induced |
GlaxoSmithKline |
2008-03-10 | PHASE3 |
| NCT01036854 | COMPLETED | Nausea |
Forest Laboratories |
2009-02 | PHASE1 |
| NCT00981487 | COMPLETED | Nausea |
Forest Laboratories |
2009-02 | PHASE1 |
| NCT00382642 | COMPLETED | Alcohol Dependence |
Bankole Johnson |
2006-06 | PHASE3 |
| NCT00905190 | COMPLETED | Nausea |
Forest Laboratories |
2009-02 | PHASE1 |
| NCT00285051 | TERMINATED | Cancer |
Rafa Laboratories |
2005-11 | PHASE2 |
| NCT01657786 | COMPLETED | Post Operative Nausea and Vomiting |
Yonsei University |
2008-05 | |
| NCT00248547 | COMPLETED | Cancer |
OHSU Knight Cancer Institute |
2004-05 | |
| NCT00314743 | COMPLETED | Nausea; Vomiting |
Washington University School of Medicine |
2005-10 | EARLY_PHASE1 |
| NCT01165866 | COMPLETED | Gastroenteritis |
Hamad Medical Corporation |
2008-06 | PHASE4 |
| NCT00796497 | COMPLETED | Obsessive Compulsive Disorder |
Institute of Neuroscience, Florence, Italy |
2008-03 | PHASE4 |
| NCT00711555 | COMPLETED | Nausea; Vomiting |
University of Illinois at Chicago |
2005-11 | PHASE2 |
| NCT00147355 | TERMINATED | HIV Infections |
Kirby Institute |
2005-11 | PHASE3 |
| NCT00337727 | COMPLETED | Chemotherapy-Induced Nausea and Vomiting |
Merck Sharp & Dohme LLC |
2007-01-01 | PHASE3 |
| NCT01217801 | COMPLETED | Healthy |
MonoSol Rx |
2008-10 | PHASE1 |
| NCT00655642 | TERMINATED | Nausea |
Vanderbilt University |
2007-03 | |
| NCT01217190 | COMPLETED | Nausea and Vomiting, Postoperative; Nausea With Vomiting Chemotherapy-Induced |
MonoSol Rx |
2008-09-16 | PHASE1; PHASE2 |
| NCT00590317 | COMPLETED | Nausea and Vomiting |
Emory University |
2005-03 | PHASE2 |
| NCT00699894 | WITHDRAWN | Postoperative Nausea and Vomiting |
Northwell Health |
2008-06 | |
| NCT01220167 | COMPLETED | Healthy Participants |
Aquestive Therapeutics |
2008-08 | PHASE1 |
| NCT00539721 | COMPLETED | Postoperative Nausea and Vomiting |
Merck Sharp & Dohme LLC |
2007-10 | PHASE2 |
| NCT00678457 | COMPLETED | Alcohol Dependence |
University of Virginia |
2007-01 | PHASE2 |
| NCT00609765 | TERMINATED | Pancreatic Cancer |
H. Lee Moffitt Cancer Center and Research Institute |
2007-08 | PHASE2 |
| NCT00825071 | COMPLETED | Postoperative Nausea and Vomiting |
University of Jordan |
2007-11 | PHASE4 |
| NCT00499668 | WITHDRAWN | Myeloproliferative Disorders; Leukemia; Lymphoma; Lymphoproliferative Disorder; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Nausea and Vomiting; Solid Tumor |
Vanderbilt-Ingram Cancer Center |
2007-08 | |
| NCT00431236 | COMPLETED | Nausea and Vomiting, Chemotherapy-Induced |
GlaxoSmithKline |
2006-11-06 | PHASE3 |
| NCT00366834 | COMPLETED | Vomiting; Nausea; Nausea and Vomiting, Chemotherapy-Induced |
GlaxoSmithKline |
2006-07 | PHASE3 |
| NCT00674713 | COMPLETED | Cholelithiasis |
Catholic University of the Sacred Heart |
2006-01 | PHASE4 |
| NCT00437229 | COMPLETED | Nausea and Vomiting, Chemotherapy-Induced |
GlaxoSmithKline |
2007-02-19 | PHASE1 |
| NCT01352130 | COMPLETED | Prolonged QTc Interval |
Tata Memorial Hospital |
2007-03 | PHASE4 |
| NCT00778011 | COMPLETED | Nausea; Vomiting |
WellSpan Health |
2005-11 | PHASE4 |
| NCT00387556 | COMPLETED | Conscious Sedation |
University of Colorado, Denver |
2002-12 | |
| NCT01511705 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2006-10 | PHASE1 |
| NCT01511718 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2006-10 | PHASE1 |
| NCT00080444 | COMPLETED | Vomiting |
Merck Sharp & Dohme LLC |
2004-04 | PHASE3 |
| NCT01523119 | COMPLETED | Healthy |
Ranbaxy Laboratories Limited |
2006-07 | |
| NCT01523093 | COMPLETED | Healthy |
Ranbaxy Laboratories Limited |
2006-07 | |
| NCT00600990 | COMPLETED | Postoperative Nausea and Vomiting; Nausea and Vomiting, Postoperative |
GlaxoSmithKline |
2004-12 | PHASE2 |
| NCT00137202 | COMPLETED | Itching |
United States Army Institute of Surgical Research |
2005-06 | |
| NCT00104403 | COMPLETED | Nausea and Vomiting, Chemotherapy-Induced; Chemotherapy-Induced Nausea and Vomiting |
GlaxoSmithKline |
2004-12 | PHASE2 |
| NCT00231777 | COMPLETED | Post-Operative Nausea and Vomiting |
Merck Sharp & Dohme LLC |
2005-07 | PHASE3 |
| NCT00108095 | COMPLETED | Postoperative Nausea and Vomiting; Nausea and Vomiting, Postoperative |
GlaxoSmithKline |
2004-10 | PHASE2 |
| NCT00274690 | COMPLETED | Postoperative Nausea and Vomiting; Nausea and Vomiting, Postoperative |
GlaxoSmithKline |
2005-02 | PHASE2 |
| NCT00648804 | COMPLETED | Healthy |
Mylan Pharmaceuticals Inc |
2005-07 | PHASE1 |
| NCT00649363 | COMPLETED | Healthy |
Mylan Pharmaceuticals Inc |
2005-07 | PHASE1 |
| NCT00090246 | COMPLETED | Postoperative Nausea and Vomiting |
Merck Sharp & Dohme LLC |
2004-05-13 | PHASE3 |
| NCT00120744 | COMPLETED | Gastroenteritis; Vomiting; Diarrhea; Dehydration |
The Hospital for Sick Children |
2004-01 | |
| NCT00090155 | COMPLETED | Postoperative Nausea and Vomiting |
Merck Sharp & Dohme LLC |
2003-09-26 | PHASE3 |
| NCT00020657 | COMPLETED | Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific |
Gary Morrow |
2001-07 | PHASE3 |
| NCT00947128 | COMPLETED | Nausea; Vomiting |
Sandoz |
2004-09 | PHASE1 |
| NCT00090207 | COMPLETED | Nausea; Vomiting |
Merck Sharp & Dohme LLC |
2004-01-13 | PHASE4 |
| NCT00946387 | COMPLETED | Nausea; Vomiting |
Sandoz |
2004-09 | PHASE1 |
| NCT00972595 | COMPLETED | Chemotherapy-Induced Nausea and Vomiting |
Merck Sharp & Dohme LLC |
2004-06 | PHASE1 |
| NCT00642512 | COMPLETED | Chemotherapy Induced Nausea and Vomiting |
Solvay Pharmaceuticals |
2003-07 | PHASE3 |
| NCT00016380 | COMPLETED | Cancer |
NCIC Clinical Trials Group |
2001-02-28 | PHASE3 |
| NCT00659074 | COMPLETED | Healthy |
Par Pharmaceutical, Inc. |
2003-10 | PHASE1 |
| NCT00092183 | COMPLETED | Nausea; Vomiting; Breast Neoplasms |
Merck Sharp & Dohme LLC |
2002-10-10 | PHASE4 |
| NCT00971633 | COMPLETED | Chemotherapy-Induced Nausea and Vomiting |
Merck Sharp & Dohme LLC |
2003-11 | PHASE1 |
| NCT00649532 | COMPLETED | Healthy |
Mylan Pharmaceuticals Inc |
2003-07 | PHASE1 |
| NCT00648583 | COMPLETED | Healthy |
Mylan Pharmaceuticals Inc |
2003-07 | PHASE1 |
| NCT00934921 | COMPLETED | Healthy |
Teva Pharmaceuticals USA |
2003-02 | PHASE1 |
| NCT00934180 | COMPLETED | Healthy |
Teva Pharmaceuticals USA |
2002-12 | PHASE1 |
| NCT00653458 | COMPLETED | Healthy |
Par Pharmaceutical, Inc. |
2002-08 | PHASE1 |
| NCT00654277 | COMPLETED | Healthy |
Par Pharmaceutical, Inc. |
2002-08 | PHASE1 |
| NCT00006348 | COMPLETED | Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Nausea and Vomiting; Precancerous Condition; Small Intestine Cancer; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific |
Alliance for Clinical Trials in Oncology |
2000-10 | PHASE3 |
| NCT00005994 | COMPLETED | Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific |
University of Rochester |
2000-08 | |
| NCT00003817 | COMPLETED | Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific |
Gary Morrow |
1999-10 | PHASE2 |
| NCT00000289 | COMPLETED | Tobacco Use Disorder |
National Institute on Drug Abuse (NIDA) |
1998-05 | PHASE2 |
| NCT00018850 | COMPLETED | Schizophrenia |
US Department of Veterans Affairs |
1998-06 | |
| NCT00000443 | COMPLETED | Alcoholism |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
PHASE2 | |
| NCT00199329 | COMPLETED | Postoperative Nausea and Vomiting |
Khon Kaen University |
2005-01 | |
| NCT00027079 | COMPLETED | Alcoholism |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
2001-09 | PHASE2 |
| NCT00429832 | COMPLETED | Nausea; Vomiting |
University of New Mexico |
2003-10 | PHASE4 |
| NCT00040053 | COMPLETED | Amphetamine-Related Disorders |
National Institute on Drug Abuse (NIDA) |
2002-06 | PHASE2 |
| NCT00659685 | COMPLETED | Healthy |
Par Pharmaceutical, Inc. |
2003-11 | PHASE1 |
| NCT00169572 | COMPLETED | Nausea and Vomiting; Chemotherapy-Induced |
GlaxoSmithKline |
2005-02 | PHASE2 |
| NCT00183222 | COMPLETED | Alcohol Dependence |
Medical University of South Carolina |
2005-05 | PHASE2 |
| NCT00033085 | COMPLETED | Cocaine-Related Disorders; Drug Administration Schedule |
National Institute on Drug Abuse (NIDA) |
2001-05 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-08-20)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).