Omeprazole is evaluated across numerous clinical trials spanning Early Phase 1 through Phase 4, encompassing completed, recruiting, terminated, withdrawn, and not yet recruiting studies. Driven by major institutional and industry sponsors such as the National Cancer Institute, Pfizer, Vertex Pharmaceuticals, Bayer, and Idorsia Pharmaceuticals, these trials investigate conditions including gastroesophageal reflux disease, non-erosive gastroesophageal reflux disease, colorectal neoplasia, obesity, pain, and nonalcoholic steatohepatitis. Furthermore, these clinical evaluations include focused drug-interaction studies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06509139 | ENROLLING_BY_INVITATION | Helicobacter Pylori Infection; Sex; Bismuth Quadruple Therapy |
National Cheng-Kung University Hospital |
2024-07-09 | PHASE4 |
| NCT07144657 | NOT_YET_RECRUITING | MALT Lymphoma of Stomach |
National Taiwan University Hospital |
2025-09-01 | PHASE2 |
| NCT06526455 | NOT_YET_RECRUITING | Ulcers, Gastric |
Shicai Ye |
2024-08-01 | PHASE4 |
| NCT06903585 | NOT_YET_RECRUITING | Bone Pain Flare; Bone Metastasis |
American University of Beirut Medical Center |
2025-04 | PHASE2 |
| NCT03866668 | RECRUITING | Autism; Autism Spectrum Disorder |
Stanford University |
2019-05-29 | PHASE2 |
| NCT06114836 | RECRUITING | GERD in Infants |
Nationwide Children's Hospital |
2024-03-14 | |
| NCT07791849 | RECRUITING | Hematopoietic Stem Cell Transplantation (HSCT); aGVHD; Infection; Mortality; Microbiome |
First Affiliated Hospital of Zhejiang University |
2026-09-15 | |
| NCT04527055 | ENROLLING_BY_INVITATION | Helicobacter Pylori Infection; Dysbiosis; Probiotics |
National Cheng-Kung University Hospital |
2020-05-06 | PHASE4 |
| NCT04448028 | RECRUITING | Liver Cirrhosis |
Universitätsklinikum Hamburg-Eppendorf |
2021-04-22 | PHASE4 |
| NCT04337580 | RECRUITING | Prostate Cancer; Refractory Cancer; Castration Resistant Prostatic Cancer |
Wake Forest University Health Sciences |
2021-03-05 | PHASE2 |
| NCT07772700 | NOT_YET_RECRUITING | Bleeding |
National Cheng-Kung University Hospital |
2026-09-01 | |
| NCT06719622 | ENROLLING_BY_INVITATION | Crohn Disease (CD) |
Medical University of Warsaw |
2024-07-30 | PHASE2; PHASE3 |
| NCT06955520 | RECRUITING | GERD |
Asian Institute of Gastroenterology, India |
2025-04-30 | |
| NCT07729293 | NOT_YET_RECRUITING | Helicobacter Pylori Infection; Dyspepsia; Gastrointestinal Adverse Effects |
Gala Servicios Clinicos S.L. |
2026-08-31 | |
| NCT07746934 | NOT_YET_RECRUITING | Helicobacter Pylori Infection |
University of Medicine and Pharmacy at Ho Chi Minh City |
2026-07-27 | |
| NCT07654049 | NOT_YET_RECRUITING | Gastrointestinal and Digestive Disorder |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2026-06-01 | |
| NCT06150898 | RECRUITING | Early-stage Breast Cancer; Estrogen-receptor-positive Breast Cancer |
Jules Bordet Institute |
2025-05-12 | PHASE2 |
| NCT02373280 | RECRUITING | Helicobacter Infection |
Seoul National University Bundang Hospital |
2014-08 | |
| NCT06783257 | NOT_YET_RECRUITING | Peptic Ulcer Bleeding |
Shandong New Time Pharmaceutical Co., LTD |
2025-02 | PHASE2 |
| NCT07790549 | NOT_YET_RECRUITING | Non-Erosive Gastroesophageal Reflux Disease (NERD) |
Liaquat University of Medical & Health Sciences |
2026-09-07 | |
| NCT06733675 | RECRUITING | Healthy Volunteer; Pharmacokinetics; Safety; Drug-Drug Interaction (DDI); FDC |
Basilea Pharmaceutica |
2025-01-07 | PHASE1 |
| NCT06510010 | RECRUITING | Chemotherapy Effect |
Sixth Affiliated Hospital, Sun Yat-sen University |
2024-12-31 | PHASE2 |
| NCT07312370 | NOT_YET_RECRUITING | Early Gastric Cancer; Gastric Dysplasia; Gastric Neoplasms; Peptic Ulcer With Haemorrhage; Gastric Ulcer |
LanZhou University |
2026-04-20 | PHASE4 |
| NCT05517928 | RECRUITING | Healthy |
Mayo Clinic |
2023-03-03 | |
| NCT06953986 | RECRUITING | GERD |
Asian Institute of Gastroenterology, India |
2025-12-20 | |
| NCT07565441 | NOT_YET_RECRUITING | ADPKD (Autosomal Dominant Polycystic Kidney Disease) |
Jemincare |
2026-05-11 | PHASE1 |
| NCT06383338 | RECRUITING | Hodgkin Lymphoma; Non Hodgkin Lymphoma |
Murdoch Childrens Research Institute |
2025-07-22 | PHASE1 |
| NCT06562907 | RECRUITING | Weight Management |
Gilead Sciences |
2024-08-28 | PHASE1 |
| NCT07037888 | RECRUITING | Femoracetabular Impingement; Hip Arthroscopy |
Henry Ford Health System |
2023-12-13 | PHASE4 |
| NCT07139366 | RECRUITING | Gastritis; Dyspepsia; Helicobacter Pylori Infection; Gastric Cancer; Peptic Ulcer |
Yongquan Shi |
2025-10-28 | PHASE4 |
| NCT06861478 | RECRUITING | Morbidity |
Universidad Autonoma de Nuevo Leon |
2024-10-20 | PHASE2 |
| NCT07700953 | RECRUITING | Healthy Participants |
Abbisko Therapeutics Co, Ltd |
2026-07-21 | PHASE1 |
| NCT07268820 | RECRUITING | GERD |
Incheon St.Mary's Hospital |
2025-07-07 | PHASE4 |
| NCT06378398 | COMPLETED | Colorectal Neoplasia |
University of Michigan Rogel Cancer Center |
2024-06-14 | EARLY_PHASE1 |
| NCT06539494 | UNKNOWN | MASLD |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
2024-07-01 | PHASE2 |
| NCT07294846 | COMPLETED | Healthy Volunteers; Patients |
Jiangsu Sinorda Biomedicine Co., Ltd |
2025-09-08 | PHASE1 |
| NCT06690164 | RECRUITING | Metabolite |
National University Hospital, Singapore |
2025-06-12 | PHASE4 |
| NCT06851468 | COMPLETED | Helicobacter Pylori |
Key Laboratory for Gastrointestinal Diseases of Gansu Province |
2025-03-15 | |
| NCT05647278 | COMPLETED | Helicobacter Pylori Infection |
Zhang Xiaofeng,MD |
2023-11-01 | PHASE4 |
| NCT07563491 | COMPLETED | Gastro Esophageal Reflux |
Muhammad Aamir Latif |
2025-01-01 | |
| NCT06523764 | ACTIVE_NOT_RECRUITING | Helicobacter Pylori Infection Chronic Gastrit |
Xijing Hospital of Digestive Diseases |
2024-11-11 | PHASE4 |
| NCT07068841 | COMPLETED | Pharmacokinetic Profiles; Y-3 for Injection; Drug-drug Interaction; Repaglinide Tablets; Warfarin Sodium Tablets; Omeprazole Enteric-coated Capsules; Safty |
Neurodawn Pharmaceutical Co., Ltd. |
2025-05-18 | PHASE1 |
| NCT06948006 | COMPLETED | Healthy Participants |
AstraZeneca |
2025-04-23 | PHASE1 |
| NCT05487235 | COMPLETED | Advanced Solid Tumors; Metastatic Solid Tumors |
Genentech, Inc. |
2022-08-17 | PHASE1 |
| NCT06949124 | COMPLETED | Endometriosis; Uterine Fibroids; Assisted Reproduction |
Jiangsu HengRui Medicine Co., Ltd. |
2025-04-28 | PHASE1 |
| NCT06359015 | TERMINATED | Preeclampsia Severe; Pre-Eclampsia; Preeclampsia; Preeclampsia Second Trimester; Preeclampsia Complicating Childbirth; Preeclampsia Puerperium; Preterm |
Christiana Care Health Services |
2021-02-11 | PHASE4 |
| NCT06302049 | UNKNOWN | Fatty Liver Disease; Steatohepatitis, Nonalcoholic |
Sadat City University |
2024-06-01 | PHASE1; PHASE2 |
| NCT06514274 | COMPLETED | Helicobacter Pylori Infection; Chronic Gastritis |
Xijing Hospital of Digestive Diseases |
2024-09-20 | PHASE4 |
| NCT06720610 | NOT_YET_RECRUITING | Erosive Esophagitis |
Indonesia University |
2024-12-09 | PHASE4 |
| NCT06850480 | RECRUITING | Reflux Esophagitis (RE) |
Livzon Pharmaceutical Group Inc. |
2024-12-05 | PHASE3 |
| NCT06279234 | COMPLETED | Type 2 Diabetes Mellitus (T2DM); Obesity |
Pfizer |
2024-02-20 | PHASE1 |
| NCT06793943 | COMPLETED | Healthy Volunteers |
Takeda |
2025-01-23 | PHASE1 |
| NCT06811207 | UNKNOWN | HELICOBACTER PYLORI INFECTIONS |
Chang Gung Memorial Hospital |
2025-02-01 | PHASE3 |
| NCT05726734 | UNKNOWN | Helicobacter Pylori Infection |
Shanghai East Hospital |
2023-02-06 | PHASE4 |
| NCT06283381 | UNKNOWN | Obesity |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
2024-02-01 | PHASE4 |
| NCT06566794 | COMPLETED | Drug Interaction |
Helsinki University Central Hospital |
2024-08-22 | |
| NCT04720781 | COMPLETED | Gastroesophageal Reflux |
Showa Inan General Hospital |
2021-01-21 | |
| NCT05590286 | UNKNOWN | Vonoprazan; Helicobacter Pylori Infection; Proton Pump Inhibitor |
First People's Hospital of Hangzhou |
2022-06-01 | PHASE4 |
| NCT05232994 | UNKNOWN | Preeclampsia Severe; Preeclampsia Second Trimester; Preterm Birth Complication |
Christiana Care Health Services |
2023-03-01 | PHASE1 |
| NCT05850117 | UNKNOWN | Helicobacter Pylori Eradication |
Kaohsiung Medical University |
2020-02-10 | |
| NCT06318104 | UNKNOWN | Helicobacter Pylori Infection |
Hospital General de México Dr. Eduardo Liceaga |
2024-04-19 | PHASE4 |
| NCT06233149 | UNKNOWN | Healthy Subjects |
Bio-innova Co., Ltd |
2024-10-01 | PHASE1 |
| NCT06164834 | UNKNOWN | Healthy |
HK inno.N Corporation |
2023-12-05 | PHASE1 |
| NCT06494761 | COMPLETED | Healthy |
Boehringer Ingelheim |
2024-07-30 | PHASE1 |
| NCT06233097 | UNKNOWN | Healthy Subjects |
Bio-innova Co., Ltd |
2024-08-29 | PHASE1 |
| NCT05891119 | COMPLETED | Atopic Dermatitis |
Amgen |
2023-06-03 | EARLY_PHASE1 |
| NCT05741385 | COMPLETED | Liver Cirrhosis |
Boehringer Ingelheim |
2023-10-10 | |
| NCT04149470 | UNKNOWN | Eosinophilic Esophagitis |
University of Colorado, Denver |
2020-10-07 | PHASE4 |
| NCT06419660 | COMPLETED | Healthy |
Boehringer Ingelheim |
2024-05-22 | PHASE1 |
| NCT06366243 | COMPLETED | Healthy Participants |
Cerevel Therapeutics, LLC |
2024-05-10 | PHASE1 |
| NCT06378658 | COMPLETED | Advanced Non-small Cell Lung Cancer; EGFR Mutation; HER2 Mutation; Healthy Volunteers |
Bayer |
2024-03-29 | PHASE1 |
| 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 |
| NCT06250634 | COMPLETED | Helicobacter Pylori Infection |
The Third Xiangya Hospital of Central South University |
2024-02-10 | |
| NCT06275841 | COMPLETED | Healthy |
Pfizer |
2024-02-23 | PHASE1 |
| NCT06378398 | Not yet recruiting | Colorectal Neoplasia |
University of Michigan Rogel Cancer Center|National Cancer Institute (NCI) |
2024-05 | Early Phase 1 |
| NCT06193811 | COMPLETED | Healthy |
Boehringer Ingelheim |
2024-01-16 | PHASE1 |
| NCT06162169 | COMPLETED | Healthy Subjects |
Allist Pharmaceuticals, Inc. |
2023-11-25 | PHASE1 |
| NCT05431075 | COMPLETED | Helicobacter Pylori Infection |
Shandong University |
2022-07-01 | PHASE4 |
| NCT05742568 | COMPLETED | Gastritis; Dyspepsia; Helicobacter Pylori Infection; Gastric Cancer; Peptic Ulcer |
Xijing Hospital of Digestive Diseases |
2022-12-01 | PHASE4 |
| NCT02476097 | UNKNOWN | Stomach Diseases |
Victoria Rollason |
2015-06 | PHASE4 |
| NCT05671653 | TERMINATED | Obesity |
Pfizer |
2023-01-19 | PHASE1 |
| NCT05981365 | COMPLETED | Sickle Cell Disease |
Pfizer |
2023-04-17 | PHASE1 |
| NCT05870683 | UNKNOWN | Helicobacter Pylori Infection |
Yanqing Li |
2023-05-24 | |
| NCT05577468 | COMPLETED | Helicobacter Pylori Infection |
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. |
2022-10-30 | PHASE3 |
| NCT03720366 | COMPLETED | Leukemia, Myeloid, Acute |
Celgene |
2018-10-04 | PHASE1 |
| NCT05932277 | COMPLETED | Healthy Volunteers |
Bristol-Myers Squibb |
2023-06-29 | PHASE1 |
| NCT05852769 | COMPLETED | Healthy Volunteers |
Bristol-Myers Squibb |
2023-05-31 | PHASE1 |
| NCT06145217 | COMPLETED | Drug-drug Interaction Study |
Xspray Pharma AB |
2023-08-22 | PHASE1 |
| NCT03452865 | COMPLETED | Sepsis; Septic Shock |
Università Vita-Salute San Raffaele |
2020-01-28 | PHASE3 |
| NCT03267680 | TERMINATED | Cervical Squamous Cell Carcinoma In Situ; Vulvar High Grade Squamous Intraepithelial Lesion |
University of Southern California |
2017-11-08 | PHASE2 |
| NCT05635110 | COMPLETED | Pain |
Vertex Pharmaceuticals Incorporated |
2022-12-15 | PHASE1 |
| NCT04652284 | UNKNOWN | Helicobacter Infections; Resistance Bacterial; Gastritis H Pylori |
Rabin Medical Center |
2021-05-01 | PHASE3 |
| NCT05264142 | UNKNOWN | Healthy |
University Hospital, Geneva |
2022-04-01 | PHASE1 |
| NCT04672018 | COMPLETED | Gastritis |
University of Karachi |
2022-11-08 | PHASE2 |
| NCT05651074 | UNKNOWN | Healthy Subjects |
Jiangsu vcare pharmaceutical technology co., LTD |
2022-11-14 | PHASE1 |
| NCT05467475 | COMPLETED | Healthy |
Boehringer Ingelheim |
2022-10-18 | PHASE1 |
| NCT05609929 | COMPLETED | Pharmacokinetic Study |
Nuvation Bio Inc. |
2022-11-02 | PHASE1 |
| NCT05671653 | Terminated | Obesity |
Pfizer |
2023-01-19 | Phase 1 |
| NCT05176821 | UNKNOWN | H. Pylori Infection |
Shanghai Zhongshan Hospital |
2021-01-01 | |
| NCT05250050 | WITHDRAWN | Helicobacter Pylori Infection |
Shanghai Zhongshan Hospital |
2022-03-25 | PHASE4 |
| NCT05438303 | COMPLETED | Healthy Volunteers |
AstraZeneca |
2022-06-13 | PHASE1 |
| NCT05635110 | Completed | Pain |
Vertex Pharmaceuticals Incorporated |
2022-12-15 | Phase 1 |
| NCT03551691 | COMPLETED | Pancreatic Insufficiency; Cystic Fibrosis |
Children's Hospital of Philadelphia |
2018-08-07 | PHASE2 |
| NCT05444556 | COMPLETED | Healthy |
Eli Lilly and Company |
2022-07-07 | PHASE1 |
| NCT05651074 | Recruiting | Healthy Subjects |
Jiangsu vcare pharmaceutical technology co. LTD |
2022-11-14 | Phase 1 |
| NCT04718740 | COMPLETED | Recurrent Ovarian Cancer |
Jiangsu HengRui Medicine Co., Ltd. |
2021-06-25 | PHASE1 |
| NCT04879992 | COMPLETED | Helicobacter Pylori Infection |
Shanghai Jiao Tong University School of Medicine |
2021-05-07 | |
| NCT04721704 | UNKNOWN | H Pylori Gastritis |
Shaheed Zulfiqar Ali Bhutto Medical University |
2020-09-14 | |
| NCT05368831 | COMPLETED | Healthy Volunteers |
NorthSea Therapeutics B.V. |
2022-07-19 | PHASE1 |
| NCT03864042 | COMPLETED | Advanced Solid Tumors; Metastatic Melanoma |
Pfizer |
2018-01-02 | PHASE1 |
| NCT04991584 | UNKNOWN | Helicobacter Pylori Infection |
Shandong University |
2021-08-04 | |
| NCT04558502 | UNKNOWN | Helicobacter Pylori Eradication |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2022-01-05 | PHASE4 |
| NCT04959266 | TERMINATED | Advanced Solid Tumours |
AstraZeneca |
2021-06-28 | PHASE1 |
| NCT05841394 | COMPLETED | Stress Ulcer Bleeding |
Livzon Pharmaceutical Group Inc. |
2021-07-16 | PHASE3 |
| NCT05254548 | COMPLETED | Healthy |
Idorsia Pharmaceuticals Ltd. |
2022-02-18 | PHASE1 |
| NCT04840888 | COMPLETED | Healthy |
Eli Lilly and Company |
2021-04-26 | PHASE1 |
| NCT05051566 | COMPLETED | Healthy |
Eli Lilly and Company |
2021-09-16 | PHASE1 |
| NCT05100446 | UNKNOWN | Helicobacter Pylori Infection; Gastritis; Gastric Cancer |
Unidade Local de Saúde do Alto Ave, EPE |
2021-05-01 | EARLY_PHASE1 |
| NCT05861687 | COMPLETED | Helicobacter Pylori Infection |
Finni Kollins |
2021-08-01 | PHASE2; PHASE3 |
| NCT05863858 | COMPLETED | Helicobacter Pylori Infection; Helicobacter Pylori Infection, Susceptibility to |
Iyad Naeem Muhammad, PhD |
2020-06-01 | PHASE3 |
| NCT03717740 | UNKNOWN | Pre-Eclampsia |
Aswan University Hospital |
2018-12-01 | PHASE3 |
| NCT04333407 | TERMINATED | COVID-19 |
Imperial College London |
2020-04-03 | |
| NCT04309916 | COMPLETED | Erosive Reflux Disease |
HK inno.N Corporation |
2020-05-22 | PHASE4 |
| NCT03358706 | TERMINATED | Crohn Disease; Ulcerative Colitis |
Janssen Research & Development, LLC |
2018-02-02 | PHASE1 |
| NCT05041920 | COMPLETED | Tumor |
Jiangsu HengRui Medicine Co., Ltd. |
2021-09-07 | PHASE1 |
| NCT03238534 | COMPLETED | GERD; EPS |
Aboca Spa Societa' Agricola |
2017-09-12 | PHASE4 |
| NCT03555526 | UNKNOWN | H Pylori Infection |
National Taiwan University Hospital |
2017-12-15 | PHASE4 |
| NCT04696783 | UNKNOWN | Gastroesophageal Reflux Disease |
Fifth Affiliated Hospital, Sun Yat-Sen University |
2021-07 | PHASE3 |
| NCT04942652 | COMPLETED | Achlorhydria |
Seoul National University Hospital |
2021-07-13 | PHASE1 |
| NCT04568772 | COMPLETED | Gastroesophageal Reflux Disease |
Seoul National University Hospital |
2020-11-25 | PHASE1 |
| NCT04432233 | UNKNOWN | Helicobacter Pylori Infection; Intravenous Drug Usage |
Shanghai Jiao Tong University School of Medicine |
2020-06-15 | PHASE4 |
| NCT06215430 | COMPLETED | Healthy |
Eli Lilly and Company |
2021-01-11 | PHASE1 |
| NCT04024527 | COMPLETED | Helicobacter Pylori Infection |
Shanghai Jiao Tong University School of Medicine |
2019-07-25 | PHASE4 |
| NCT05038969 | COMPLETED | Healthy |
Genuine Research Center, Egypt |
2021-03-18 | PHASE1 |
| NCT03908619 | UNKNOWN | Helicobacter Pylori Infection |
Changi General Hospital |
2019-04-16 | PHASE4 |
| NCT04679948 | COMPLETED | Healthy |
Boehringer Ingelheim |
2020-12-21 | PHASE1 |
| NCT04425902 | COMPLETED | HIV Infections |
ViiV Healthcare |
2020-12-16 | PHASE1 |
| NCT02724150 | WITHDRAWN | Gastroduodenal Ulcer; Marginal Ulcer; Peptic Ulcer Hemorrhage |
Damascus Hospital |
2017-12-01 | PHASE4 |
| NCT04643249 | COMPLETED | Mitochondrial Disease |
Abliva AB |
2020-11-10 | PHASE1 |
| NCT05287633 | COMPLETED | Dyspepsia |
University of Monastir |
2020-01-20 | PHASE1; PHASE2 |
| NCT05237115 | COMPLETED | Gastritis; Peptic Ulcer; Dyspepsia |
Xijing Hospital of Digestive Diseases |
2020-05-05 | PHASE4 |
| NCT04170270 | UNKNOWN | Bleeding Peptic Ulcer |
Assiut University |
2019-11 | EARLY_PHASE1 |
| NCT03717701 | UNKNOWN | Pre-Eclampsia |
Aswan University Hospital |
2018-12-01 | |
| NCT04282954 | COMPLETED | GERD |
Onconic Therapeutics Inc. |
2019-11-15 | PHASE2 |
| NCT04468815 | COMPLETED | Healthy Participants |
Bristol-Myers Squibb |
2020-07-10 | PHASE1 |
| NCT03781596 | UNKNOWN | Eosinophilic Esophagitis |
Claire Daniels |
2018-10-02 | PHASE4 |
| NCT04368585 | COMPLETED | Healthy Volunteers |
Spero Therapeutics |
2020-07-01 | PHASE1 |
| NCT02760615 | WITHDRAWN | Colitis, Ulcerative; Crohn Disease |
Takeda |
2016-11-01 | PHASE4 |
| NCT03488147 | WITHDRAWN | Dysphagia; GERD; Degenerative Joint Disease |
Icahn School of Medicine at Mount Sinai |
2020-07 | PHASE2 |
| NCT03213639 | COMPLETED | Preeclampsia |
Assiut University |
2018-03-15 | PHASE2; PHASE3 |
| NCT04445948 | COMPLETED | Helicobacter Pylori Infection |
Alexandria University |
2019-11-30 | PHASE4 |
| NCT03688828 | COMPLETED | Helicobacter Pylori Infection |
Huazhong University of Science and Technology |
2018-11-11 | |
| NCT03367195 | TERMINATED | Gastroesophageal Reflux Disease (GERD) |
Dexa Medica Group |
2018-08-16 | PHASE3 |
| NCT03726099 | UNKNOWN | Helicobacter Pylori Infection |
Shandong University |
2019-03-15 | PHASE4 |
| NCT03980756 | COMPLETED | Gastritis |
Addpharma Inc. |
2019-06-05 | PHASE1 |
| NCT03556592 | COMPLETED | Atopic Dermatitis |
LEO Pharma |
2018-08-13 | PHASE1 |
| NCT04090021 | UNKNOWN | Helicobacter Pylori Infection |
Konstantopoulio-Patission General Hospital of Nea Ionia |
2019-09-01 | PHASE4 |
| NCT04142762 | COMPLETED | Chronic Hepatitis B |
Assembly Biosciences |
2019-10-18 | PHASE1 |
| NCT02081404 | COMPLETED | Non-erosive Reflux Disease |
Midwest Biomedical Research |
2009-03-01 | |
| NCT04156646 | COMPLETED | Autism Spectrum Disorder |
Hoffmann-La Roche |
2019-11-19 | PHASE1 |
| NCT03708211 | COMPLETED | Neoplasms, Advanced Solid |
Millennium Pharmaceuticals, Inc. |
2019-03-28 | PHASE1 |
| NCT02595372 | COMPLETED | Cancer of the Breast |
Kathy Miller |
2015-11-12 | PHASE2 |
| NCT04138836 | COMPLETED | Healthy Participants |
Bridge Biotherapeutics, Inc. |
2019-09-17 | PHASE1 |
| NCT03615677 | COMPLETED | Erosive Esophagitis (EE) |
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. |
2018-10-24 | PHASE3 |
| NCT03708848 | COMPLETED | Helicobacter Pylori Infection |
Shanghai Jiao Tong University School of Medicine |
2018-12-05 | PHASE4 |
| NCT04108676 | COMPLETED | Advanced Solid Tumor |
Jiangsu HengRui Medicine Co., Ltd. |
2019-09-07 | PHASE1 |
| NCT03658733 | UNKNOWN | Helicobacter Pylori Infection |
Shandong University |
2018-12-15 | PHASE4 |
| NCT03936374 | COMPLETED | Healthy |
Bristol-Myers Squibb |
2019-05-08 | PHASE1 |
| NCT03557437 | COMPLETED | Helicobacter Pylori Infection |
Shanghai Jiao Tong University School of Medicine |
2018-05-25 | PHASE4 |
| NCT04525664 | COMPLETED | Helicobacter Pylori Infection; Dyspepsia |
Washington University School of Medicine |
2018-10-01 | EARLY_PHASE1 |
| NCT03849690 | COMPLETED | Healthy Volunteers |
Millennium Pharmaceuticals, Inc. |
2019-02-27 | PHASE1 |
| NCT04329000 | COMPLETED | Barrett Esophagus; Proton Pump Inhibitor; Symptom; Reflux |
Kaohsiung Veterans General Hospital. |
2010-02-02 | |
| NCT03530995 | COMPLETED | Drug-drug Interaction; Autoimmune Diseases; Fibrotic Disease |
Kadmon Corporation, LLC |
2018-04-09 | PHASE1 |
| NCT02262169 | TERMINATED | Non-Bleeding Peptic Ulcers |
Dexa Medica Group |
2014-10 | PHASE3 |
| NCT03333824 | COMPLETED | Solid Tumours |
AstraZeneca |
2017-12-01 | PHASE1 |
| NCT03220542 | UNKNOWN | Helicobacter Pylori Infection |
Kyunghee University Medical Center |
2016-01 | PHASE4 |
| NCT03291249 | WITHDRAWN | NASH - Nonalcoholic Steatohepatitis; NAFLD; T2DM (Type 2 Diabetes Mellitus) |
Tiziana Life Sciences LTD |
2017-12-01 | PHASE2 |
| NCT02153177 | WITHDRAWN | Rotator Cuff Tear |
University of Chicago |
2015-01 | PHASE4 |
| NCT02422706 | UNKNOWN | Helicobacter-associated Gastritis |
Sherief Abd-Elsalam |
2015-01 | PHASE3 |
| NCT03505853 | COMPLETED | Acute Intermittent Porphyria (AIP); Acute Hepatic Porphyria (AHP); Porphyria, Acute Intermittent; Acute Porphyria |
Alnylam Pharmaceuticals |
2018-04-26 | PHASE1 |
| NCT03405584 | COMPLETED | Helicobacter Pylori Infection |
Shanghai Jiao Tong University School of Medicine |
2018-01-03 | PHASE4 |
| NCT05109390 | COMPLETED | Healthy |
Alexion Pharmaceuticals, Inc. |
2018-07-27 | PHASE1 |
| NCT02743949 | COMPLETED | Gastroesophageal Reflux |
Takeda |
2016-07-14 | PHASE2 |
| NCT03793556 | COMPLETED | Gastro-oesophageal Reflux Disease |
SOFAR S.p.A. |
2017-05-05 | |
| NCT05468164 | COMPLETED | Healthy |
Eli Lilly and Company |
2018-05-31 | PHASE1 |
| NCT04617613 | COMPLETED | Helicobacter Pylori Infection |
Al-Azhar University |
2016-09 | PHASE4 |
| NCT03530228 | UNKNOWN | Pharmacodynamics; Pharmacokinetics; Healthy Male Volunteers |
HK inno.N Corporation |
2018-05 | PHASE1 |
| NCT02584751 | UNKNOWN | Gastro Esophageal Reflux Disorder |
James J. Peters Veterans Affairs Medical Center |
2016-08 | PHASE1 |
| NCT03413020 | COMPLETED | Helicobacter Pylori Infection |
Shanghai Jiao Tong University School of Medicine |
2018-01-03 | PHASE4 |
| NCT03457727 | COMPLETED | Pulmonary Disease, Chronic Obstructive |
GlaxoSmithKline |
2018-03-07 | PHASE1 |
| NCT01287598 | COMPLETED | Neoplasms |
Bayer |
2011-08-02 | PHASE1 |
| NCT03531762 | COMPLETED | Healthy |
Merck KGaA, Darmstadt, Germany |
2018-05-14 | PHASE1 |
| NCT02685150 | COMPLETED | Gastroesophageal Reflux Disease; Dyspepsia; Bile Reflux |
Chinese PLA General Hospital |
2016-01 | |
| NCT03561233 | COMPLETED | Systemic Sclerosis; Gastroesophageal Reflux; Proton Pubm Inhibitor |
Khon Kaen University |
2013-05 | PHASE1 |
| NCT02586636 | COMPLETED | Tolerance |
NHS Tayside |
2016-03 | PHASE4 |
| NCT01458990 | COMPLETED | Cirrhosis; Healthy |
Hunter Holmes Mcguire Veteran Affairs Medical Center |
2011-10 | |
| NCT03195946 | COMPLETED | Drug Reactions |
H. Lundbeck A/S |
2017-06-16 | PHASE1 |
| NCT02959255 | COMPLETED | Helicobacter Pylori Infection |
Elpen Pharmaceutical Co. Inc. |
2017-01-30 | PHASE4 |
| NCT03100838 | COMPLETED | Healthy Volunteers |
Food and Drug Administration (FDA) |
2017-03-20 | PHASE1 |
| NCT03598738 | COMPLETED | Diabetes Mellitus, Type 2 |
Baskent University Ankara Hospital |
2015-12-01 | |
| NCT03142620 | UNKNOWN | H. Pylori Infection |
Chinese University of Hong Kong |
2015-03 | PHASE3 |
| NCT02472600 | UNKNOWN | Intestinal Colonization With Multidrug-resistant Bacteria |
Stephen Harbarth |
2016-02 | PHASE2 |
| NCT03302845 | COMPLETED | Drug-drug Interaction |
Lexicon Pharmaceuticals |
2017-09-21 | PHASE1 |
| NCT02732249 | COMPLETED | Helicobacter Pylori Infection |
Shanghai Jiao Tong University School of Medicine |
2016-04-01 | PHASE4 |
| NCT03137134 | COMPLETED | Healthy |
Pfizer |
2017-06-20 | PHASE1 |
| NCT02840929 | TERMINATED | OGD; Gastric Ulcer Induced by Anti-platelet Agent; Duodenal Ulcer Induced by Anti-platelet Agent |
The University of Hong Kong |
2016-07 | |
| NCT02978157 | COMPLETED | Helicobacter Pylori Infection |
Kaohsiung Veterans General Hospital. |
2015-02 | |
| NCT02530879 | WITHDRAWN | Laryngopharyngeal Reflux |
Temple University |
2016-05 | PHASE4 |
| NCT02547012 | COMPLETED | Helicobacter Pylori Infection |
Kaohsiung Veterans General Hospital. |
2013-11 | |
| NCT02772601 | COMPLETED | Psoriasis |
AbbVie |
2016-09-15 | PHASE1 |
| NCT01566474 | COMPLETED | Barrett's Esophagus |
Aragon Institute of Health Sciences |
2012-04 | PHASE3 |
| NCT03058419 | COMPLETED | Healthy |
Janssen Research & Development, LLC |
2017-03-14 | PHASE1 |
| NCT03059303 | TERMINATED | Healthy |
Janssen Research & Development, LLC |
2017-02-20 | PHASE1 |
| NCT00542347 | TERMINATED | Gastric Acid |
Queen's University |
2007-09 | PHASE3 |
| NCT03444831 | COMPLETED | Dyspepsia |
Isfahan University of Medical Sciences |
2016-03-01 | PHASE4 |
| NCT02740712 | COMPLETED | Neoplasms |
pharmaand GmbH |
2016-04 | PHASE1 |
| NCT03033342 | COMPLETED | Safety |
MicuRx |
2016-08-02 | PHASE1 |
| NCT02757144 | COMPLETED | Healthy |
Daewoong Pharmaceutical Co. LTD. |
2016-03 | PHASE1 |
| NCT02016820 | TERMINATED | Clostridium Difficile Infection |
Columbia University |
2014-11 | |
| NCT02013453 | WITHDRAWN | Cancer of Head and Neck |
University of Michigan Rogel Cancer Center |
2013-12 | PHASE2 |
| NCT02844621 | COMPLETED | Healthy Volunteers |
The University of Texas Health Science Center at San Antonio |
2016-05 | EARLY_PHASE1 |
| NCT01670552 | COMPLETED | Acute and Chronic Inflammation; Dyspepsia |
EMS |
2016-02-17 | PHASE3 |
| NCT02272868 | TERMINATED | Crohn's Disease |
Seattle Children's Hospital |
2015-01 | PHASE1; PHASE2 |
| NCT02085018 | COMPLETED | Idiopathic Pulmonary Fibrosis |
Newcastle-upon-Tyne Hospitals NHS Trust |
2014-03-28 | PHASE2 |
| NCT00226044 | COMPLETED | Gastroesophageal Reflux; Esophageal Atresia; Hernia, Diaphragmatic |
Rijnstate Hospital |
2005-09 | PHASE3 |
| NCT02361619 | COMPLETED | Healthy Volunteers |
Turku University Hospital |
2015-02 | PHASE1 |
| NCT02893709 | COMPLETED | Gastroesophageal Reflux Disease |
Changi General Hospital |
2015-06 | |
| NCT02456935 | COMPLETED | Erosive Esophagitis |
HK inno.N Corporation |
2015-05 | PHASE3 |
| NCT02647086 | COMPLETED | Atopic Dermatitis |
Regeneron Pharmaceuticals |
2015-12 | PHASE1 |
| NCT02790840 | COMPLETED | Healthy |
Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
2016-05-16 | PHASE1 |
| NCT02277886 | UNKNOWN | Gastroesophageal Reflux Disease; Heartburn; Sleep Disturbance |
Chang Gung Memorial Hospital |
2014-11 | PHASE4 |
| NCT02407119 | ACTIVE_NOT_RECRUITING | Helicobacter Pylori Infection; Early Gastric Cancer; Endoscopic Resection |
National Cancer Center, Korea |
2003-06 | PHASE3 |
| NCT02134405 | UNKNOWN | Dyspepsia |
University of Malaya |
2014-08 | PHASE4 |
| NCT03146325 | WITHDRAWN | Helicobacter Pylori Infection |
The University of Texas Health Science Center, Houston |
2012-11 | PHASE4 |
| NCT02684799 | COMPLETED | Healthy |
Tobira Therapeutics, Inc. |
2016-01-31 | PHASE1 |
| NCT02205489 | COMPLETED | Relapsing-remitting Multiple Sclerosis |
Genzyme, a Sanofi Company |
2014-10 | PHASE4 |
| NCT02638116 | COMPLETED | Healthy |
Janssen Research & Development, LLC |
2016-01 | PHASE1 |
| NCT03128736 | COMPLETED | Gastroesophageal Reflux Disease |
Kaohsiung Medical University Chung-Ho Memorial Hospital |
2014-04-01 | PHASE4 |
| NCT01465113 | COMPLETED | Short Segment Barrett's Esophagus; Long Segment Barrett's Esophagus |
Case Comprehensive Cancer Center |
2010-05 | EARLY_PHASE1 |
| NCT02157376 | COMPLETED | Stress Ulcer Prophylaxis |
AstraZeneca |
2014-07 | PHASE3 |
| NCT01462318 | COMPLETED | Relapsing-Remitting Multiple Sclerosis |
Biogen |
2011-11 | PHASE3 |
| NCT01408849 | TERMINATED | Dyspepsia |
Casa Espirita Terra de Ismael |
2015-02 | PHASE2 |
| NCT00951431 | COMPLETED | Functional Dyspepsia |
Chinese University of Hong Kong |
2009-12-03 | PHASE4 |
| NCT02578277 | COMPLETED | HIV Infections |
ViiV Healthcare |
2015-11-09 | PHASE1 |
| NCT03378960 | COMPLETED | Bariatric Surgery Candidate |
Emilio Vargas Castrillón |
2014-10-31 | PHASE4 |
| NCT02494856 | COMPLETED | Pain; Other Surgical Procedures; Impacted Third Molar Tooth |
Giovana Maria Weckwerth |
2014-10 | PHASE4 |
| NCT00327132 | COMPLETED | Gastric MALT Lymphoma |
National Health Research Institutes, Taiwan |
2006-07 | |
| NCT02623816 | COMPLETED | Heartburn |
MetroHealth Medical Center |
2014-08 | PHASE4 |
| NCT02515526 | COMPLETED | AOD Effects and Consequences |
University of Cologne |
2015-06 | |
| NCT03650543 | COMPLETED | CYP2C19 Polymorphism; H.Pylori Infection; Therapy |
Javeriana University |
2012-09-10 | PHASE4 |
| NCT02492776 | COMPLETED | Healthy |
Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
2015-07-07 | PHASE1 |
| NCT02453022 | COMPLETED | Pulmonary Disease, Chronic Obstructive |
GlaxoSmithKline |
2015-05-18 | PHASE1 |
| NCT01854970 | COMPLETED | Laryngopharyngeal Reflux; Oesophageal pH-impedance |
University Hospital, Bordeaux |
2013-05 | |
| NCT01777854 | TERMINATED | Laryngopharyngeal Reflux; Throat Pain |
Ascension Health |
2013-01 | PHASE4 |
| NCT02434861 | COMPLETED | Chemotherapy-induced Nausea and Vomiting |
Tesaro, Inc. |
2015-05 | PHASE1 |
| NCT02543606 | COMPLETED | Healthy |
Yung Shin Pharm. Ind. Co., Ltd. |
2015-04 | PHASE4 |
| NCT02524210 | COMPLETED | Healthy |
Centre Hospitalier Universitaire de Saint Etienne |
2014-05 | PHASE1 |
| NCT02685436 | COMPLETED | Gastroesophageal Reflux Disease |
Mansoura University Children Hospital |
2013-03 | PHASE4 |
| NCT02394340 | COMPLETED | Tinea Pedis; Tinea Cruris |
Bausch & Lomb Incorporated |
2015-02-03 | PHASE4 |
| NCT02249871 | COMPLETED | Diabetes; Healthy |
Novo Nordisk A/S |
2014-09-24 | PHASE1 |
| NCT03362281 | COMPLETED | Peptic Ulcer Hemorrhage |
Livzon Pharmaceutical Group Inc. |
2014-10 | PHASE3 |
| NCT02365558 | COMPLETED | Healthy |
Eli Lilly and Company |
2015-01 | PHASE1 |
| NCT02071316 | UNKNOWN | Upper Gastrointestinal Bleeding; Hexacapron; Hemostasis; Rebleeding; Mortality |
Shaare Zedek Medical Center |
2014-04 | |
| NCT02391688 | COMPLETED | Drug Interaction |
Jules Desmeules |
2014-11 | PHASE1 |
| NCT02028234 | UNKNOWN | Coronary Artery Disease |
University of Roma La Sapienza |
2014-02 | PHASE4 |
| NCT01678053 | WITHDRAWN | Contact Ulcer of Vocal Folds; Granuloma of Vocal Cords; Granuloma, Laryngeal; Granuloma |
Phillip Song, MD |
2012-09 | PHASE2 |
| NCT02224053 | COMPLETED | Healthy Volunteer |
AstraZeneca |
2014-09 | PHASE1 |
| NCT01757275 | COMPLETED | Bleeding Peptic Ulcer |
AstraZeneca |
2013-02 | PHASE3 |
| NCT02254148 | COMPLETED | Healthy |
Boehringer Ingelheim |
2014-10 | PHASE1 |
| NCT02299687 | COMPLETED | Stomach Ulcer |
Seoul National University Hospital |
2014-09 | PHASE1 |
| NCT01093755 | COMPLETED | Inflammation; Barrett's Esophagus |
Mayo Clinic |
2010-03 | PHASE4 |
| NCT04914936 | COMPLETED | Healthy Participants |
Acerta Pharma BV |
2014-09-21 | PHASE1 |
| NCT02197143 | COMPLETED | Dyspepsia |
Pamukkale University |
2013-03 | PHASE4 |
| NCT01596647 | COMPLETED | Advanced Solid Tumors, Excluding Breast Cancer |
Novartis Pharmaceuticals |
2012-05 | PHASE1 |
| NCT02190708 | COMPLETED | Healthy Volunteers; Pharmacologic Action |
Vivoryon Therapeutics N.V. |
2014-06 | PHASE1 |
| NCT03362268 | COMPLETED | Peptic Ulcer Hemorrhage |
Livzon Pharmaceutical Group Inc. |
2014-02 | PHASE2 |
| NCT05319912 | COMPLETED | Healthy |
Alexion Pharmaceuticals, Inc. |
2014-04-07 | PHASE1 |
| NCT02028663 | COMPLETED | Erosive Esophagitis; GERD |
HK inno.N Corporation |
2013-05 | PHASE2 |
| NCT01669811 | COMPLETED | Refractory Reflux Esophagitis |
AstraZeneca |
2012-08 | PHASE3 |
| NCT02128893 | COMPLETED | Pharmacokinetics of Isavuconazole; Healthy Subjects |
Astellas Pharma Global Development, Inc. |
2014-01 | PHASE1 |
| NCT01822977 | COMPLETED | Healthy; Clostridium Difficile Infection |
Mayo Clinic |
2013-03 | PHASE1 |
| NCT01795794 | UNKNOWN | CDA Type I |
Soroka University Medical Center |
2013-04 | PHASE4 |
| NCT01275937 | UNKNOWN | Upper Gastrointestinal Bleeding |
Taipei Medical University |
2011-08 | PHASE4 |
| NCT01934569 | COMPLETED | Healthy |
Pfizer |
2013-09 | PHASE1 |
| NCT01538849 | COMPLETED | Reflux Esophagitis |
Yuhan Corporation |
2012-12 | PHASE2 |
| NCT01750437 | COMPLETED | Non-erosive Reflux Disease |
Yuhan Corporation |
2013-01 | PHASE2 |
| NCT01517399 | COMPLETED | Solid Tumors |
Daiichi Sankyo |
2011-12 | PHASE1 |
| NCT01887249 | COMPLETED | Helicobacter Pylori Infection |
Seoul National University Bundang Hospital |
2010-05 | PHASE4 |
| NCT01876108 | COMPLETED | Fatty Liver; Liver Dysfunction; Insulin Resistance |
Tehran University of Medical Sciences |
2012-07 | PHASE2 |
| NCT03980496 | COMPLETED | Non-variceal Upper Gastrointestinal Bleeding |
Medical University of Bialystok |
2010-09-09 | PHASE4 |
| NCT01896557 | COMPLETED | Coronary Artery Disease; Drug Interaction Potentiation |
University of Sao Paulo General Hospital |
2011-10 | PHASE4 |
| NCT01667575 | COMPLETED | Functional Dyspepsia; Peptic Ulcer; Helicobacter Pylori |
Shanghai Jiao Tong University School of Medicine |
2012-08 | PHASE4 |
| NCT01813552 | COMPLETED | Chronic Hepatitis C Infection |
Merck Sharp & Dohme LLC |
2013-02 | PHASE1 |
| NCT01786382 | COMPLETED | Pharmacokinetic Assessments in Healthy Volunteers |
Presidio Pharmaceuticals, Inc. |
2013-02 | PHASE1 |
| NCT01711320 | COMPLETED | Healthy |
Xijing Hospital |
2012-09 | PHASE1 |
| NCT01016717 | WITHDRAWN | Coronary Artery Disease |
Sheba Medical Center |
2012-12 | PHASE4 |
| NCT01694706 | COMPLETED | Healthy |
Boehringer Ingelheim |
2012-09 | PHASE1 |
| NCT01138969 | COMPLETED | Peptic Ulcer |
Kaohsiung Veterans General Hospital. |
2008-08 | PHASE2 |
| NCT01539655 | COMPLETED | Medullary Thyroid Cancer |
Sanofi |
2012-02 | PHASE1 |
| NCT01269333 | COMPLETED | Drug Interaction of Clopidogrel |
Hadassah Medical Organization |
2011-01 | PHASE1 |
| NCT01361217 | COMPLETED | Drug-Drug Interaction; Healthy Volunteers |
University of Washington |
2011-09 | |
| NCT01150162 | COMPLETED | Gastric Ulcer |
Otsuka Pakistan Limited |
2010-10 | PHASE3 |
| NCT02536989 | COMPLETED | Peptic Ulcer; Hemorrhage |
Far Eastern Memorial Hospital |
2009-03 | PHASE4 |
| NCT01448031 | COMPLETED | Healthy |
AstraZeneca |
2011-11 | PHASE1 |
| NCT01275170 | COMPLETED | Infectious Disease |
Merck Sharp & Dohme LLC |
2011-01-28 | PHASE1 |
| NCT01494402 | COMPLETED | Bioequivalence Study |
AstraZeneca |
2012-01 | PHASE1 |
| NCT01911728 | COMPLETED | Pharmacokinetics of MDV3100; Castration Resistant Prostate Cancer (CRPC) |
Astellas Pharma Europe B.V. |
2011-07-25 | PHASE1 |
| NCT01338077 | COMPLETED | Gastroesophageal Reflux Disease; Heartburn |
Chang Gung Memorial Hospital |
2010-10 | PHASE3 |
| NCT01397084 | COMPLETED | Gastroesophageal Reflux Disease; GERD; Reflux Esophagitis |
AstraZeneca |
2011-08 | PHASE4 |
| NCT01142128 | TERMINATED | Chronic Pancreatitis |
University of Florida |
2009-02 | PHASE1 |
| NCT01470690 | COMPLETED | HCV Infections; Gastric Acid-related Disorders |
Radboud University Medical Center |
2011-10 | PHASE1 |
| NCT00683111 | COMPLETED | Acute Coronary Syndrome; Acute Myocardial Infarction |
Ruttonjee Hospital |
2008-07 | PHASE4 |
| NCT01452906 | COMPLETED | Healthy |
Vifor Pharma |
2011-09 | PHASE1 |
| NCT01458054 | COMPLETED | Hepatitis C |
GlaxoSmithKline |
2011-09-27 | PHASE1 |
| NCT01489943 | COMPLETED | Crohn's Disease |
GlaxoSmithKline |
2011-09-19 | PHASE1 |
| NCT01370525 | COMPLETED | Heartburn |
AstraZeneca |
2011-08 | PHASE3 |
| NCT01392755 | COMPLETED | Healthy Volunteer |
Hoffmann-La Roche |
2011-07 | PHASE1 |
| NCT00964106 | COMPLETED | Drug Interactions |
GlaxoSmithKline |
2009-08-26 | PHASE1 |
| NCT01822600 | COMPLETED | Peptic Ulcer Bleeding; Hypoalbuminemia |
National Cheng-Kung University Hospital |
2010-01 | PHASE4 |
| NCT01983774 | COMPLETED | Cystic Fibrosis |
Columbia University |
2008-02 | PHASE2 |
| NCT01269788 | COMPLETED | Non-erosive Reflux Disease |
Tehran University of Medical Sciences |
2010-08 | PHASE2; PHASE3 |
| NCT00950339 | COMPLETED | Coronary Heart Disease; GI Bleeding |
Tel-Aviv Sourasky Medical Center |
2009-08 | PHASE4 |
| NCT01059383 | COMPLETED | Gastroesophageal Reflux |
Vecta Ltd. |
2009-12 | PHASE2 |
| NCT01358383 | COMPLETED | Juvenile Idiopathic Arthritis |
AstraZeneca |
2011-05 | PHASE1 |
| NCT01119768 | COMPLETED | Non Erosive Reflux Disease; Chronic Gastritis |
AstraZeneca |
2010-04 | PHASE4 |
| NCT01335334 | UNKNOWN | H. Pylori Infection |
The University of Texas Health Science Center, Houston |
2011-03 | PHASE4 |
| NCT01147588 | COMPLETED | Healthy |
AstraZeneca |
2010-05 | PHASE1 |
| NCT02220777 | COMPLETED | Pharmacokinetics of ASP8477; Pharmacodynamics of ASP8477 |
Astellas Pharma Europe B.V. |
2010-11 | PHASE1 |
| NCT01341600 | COMPLETED | Metabolism of Clopidogrel |
University of Maryland, Baltimore |
2010-07 | |
| NCT02659683 | COMPLETED | Healthy Subjects |
Torrent Pharmaceuticals Limited |
2011-05 | PHASE1 |
| NCT02680132 | COMPLETED | Healthy |
Torrent Pharmaceuticals Limited |
2011-05 | PHASE1 |
| NCT01544517 | COMPLETED | Helicobacter Pylori Infection |
University of Campania Luigi Vanvitelli |
2011-01 | PHASE3 |
| NCT01303445 | COMPLETED | Healthy |
Boehringer Ingelheim |
2011-03 | PHASE1 |
| NCT01007019 | COMPLETED | Healthy |
Yuhan Corporation |
2009-11 | PHASE1 |
| NCT01570569 | COMPLETED | Healthy |
Inje University |
2011-01 | PHASE1 |
| NCT00290823 | COMPLETED | Neurocysticercosis |
National Institute of Allergy and Infectious Diseases (NIAID) |
2006-04 | PHASE3 |
| NCT01187862 | COMPLETED | Cytochrome; Pharmacokinetics |
University Hospital, Basel, Switzerland |
2010-07 | PHASE1 |
| NCT01337804 | COMPLETED | Heartburn |
Bayer |
2011-01 | PHASE1 |
| NCT00361985 | WITHDRAWN | Anastomotic Stricture; Morbid Obesity |
Weill Medical College of Cornell University |
2008-01 | PHASE4 |
| NCT01122160 | COMPLETED | Anthocyanin Metabolism |
USDA Beltsville Human Nutrition Research Center |
2010-05 | |
| NCT00728481 | COMPLETED | Eosinophilic Esophagitis; Gastroesophageal Reflux Disease; EE; GERD |
Mayo Clinic |
2008-05 | PHASE2; PHASE3 |
| NCT01792700 | COMPLETED | Helicobacter Infections |
Seoul National University Bundang Hospital |
2003-01 | PHASE4 |
| NCT01290380 | TERMINATED | Solid Tumor Malignancies |
Novartis Pharmaceuticals |
2010-02 | PHASE1 |
| NCT00604942 | TERMINATED | Achalasia; GORD |
Guy's and St Thomas' NHS Foundation Trust |
2007-11 | |
| NCT02620696 | COMPLETED | ECL-cell Hyperplasia; Parietal-cell Hyperplasia; Rebound Hyperacidity; Dyspepsia |
Trio Medicines Ltd. |
2009-11 | PHASE1 |
| NCT01159145 | COMPLETED | Pharmacodynamics Study |
AstraZeneca |
2010-07 | PHASE1 |
| NCT01062516 | COMPLETED | Acute Coronary Syndrome; Acute Myocardial Infarction |
Ruttonjee Hospital |
2010-01 | PHASE4 |
| NCT01153659 | COMPLETED | Healthy |
Eisai Inc. |
2010-07 | PHASE1 |
| NCT01139645 | COMPLETED | Calcium Metabolism Disorders |
American University of Beirut Medical Center |
2009-10 | |
| NCT00559182 | COMPLETED | Advanced Cancer |
Merck Sharp & Dohme LLC |
2007-12-05 | PHASE1 |
| NCT00942175 | COMPLETED | Healthy |
Takeda |
2009-12 | PHASE1 |
| NCT01107938 | UNKNOWN | Gastroesophageal Reflux Disease |
Livzon Pharmaceutical Group Inc. |
2010-05 | PHASE2 |
| NCT00971581 | COMPLETED | Pain |
Sanofi |
2009-08 | PHASE3 |
| NCT01415128 | COMPLETED | Erectile Dysfunction |
VIVUS LLC |
2010-04 | PHASE1 |
| NCT00182260 | COMPLETED | Gastroesophageal Reflux |
McMaster University |
2000-01 | |
| NCT01001247 | COMPLETED | HIV Infections |
Tibotec Pharmaceuticals, Ireland |
2010-01 | PHASE1 |
| NCT00641004 | COMPLETED | NSAID Induced Gastropathy |
Otsuka Pharmaceutical, Inc., Philippines |
2008-04 | PHASE4 |
| NCT00633035 | COMPLETED | Ulcer |
Far Eastern Memorial Hospital |
2007-09 | PHASE4 |
| NCT00989300 | COMPLETED | Healthy |
Janssen Cilag S.A.S. |
2009-11 | PHASE1 |
| NCT00567658 | WITHDRAWN | Larynx Disease |
Vanderbilt University |
2008-02 | PHASE3 |
| NCT00998075 | COMPLETED | Peptic Ulcer Disease |
AstraZeneca |
2009-09 | PHASE1 |
| NCT00557921 | TERMINATED | Acute Coronary Syndrome; Myocardial Infarction; Coronary Artery Disease; Percutaneous Coronary Intervention |
Cogentus Pharmaceuticals |
2007-12 | PHASE3 |
| NCT00825630 | COMPLETED | Helicobacter Pylori Infection |
Meridian Bioscience, Inc. |
2008-11 | PHASE4 |
| NCT00942136 | COMPLETED | Healthy Volunteer |
GlaxoSmithKline |
2009-07 | PHASE1 |
| NCT00658775 | COMPLETED | Gastroesophageal Reflux Disease (GERD) |
Eisai Inc. |
2008-02 | PHASE3 |
| NCT01129414 | COMPLETED | Healthy |
Sanofi |
2009-06 | PHASE1 |
| NCT00446004 | COMPLETED | Healthy |
University of Pittsburgh |
2007-04 | PHASE1 |
| NCT00669955 | COMPLETED | Helicobacter Infections |
Forest Laboratories |
2008-06 | PHASE3 |
| NCT00559364 | COMPLETED | Exocrine Pancreatic Insufficiency; Chronic Pancreatitis; Pancreatectomy |
Forest Laboratories |
2007-11 | PHASE3 |
| NCT00404534 | COMPLETED | Functional Dyspepsia |
Hospital de Clinicas de Porto Alegre |
2006-10 | PHASE3 |
| NCT00818870 | COMPLETED | Gastroesophageal Reflux |
Vecta Ltd. |
2008-12 | PHASE1 |
| NCT00141102 | COMPLETED | Osteoarthritis; Arthritis, Rheumatoid |
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
2005-10 | PHASE4 |
| NCT01129375 | COMPLETED | Healthy |
Sanofi |
2009-02 | PHASE1 |
| NCT00723502 | COMPLETED | Gram-Negative Bacterial Infections; Helicobacter Infections; Dyspepsia |
MerLion Pharmaceuticals GmbH |
2008-09 | PHASE2 |
| NCT00251927 | COMPLETED | Gastroesophageal Reflux |
AstraZeneca |
2001-10 | PHASE3 |
| NCT00206440 | TERMINATED | Nausea |
Baylor Breast Care Center |
2005-08 | PHASE3 |
| NCT00838682 | TERMINATED | Peptic Ulcer Hemorrhage |
The Catholic University of Korea |
2006-04 | PHASE4 |
| NCT00582972 | COMPLETED | Osteoporosis; Achlorhydria; GERD; Hip Fracture |
University of Wisconsin, Madison |
2008-01 | PHASE4 |
| NCT00492622 | COMPLETED | Gastroparesis; Gastroesophageal Reflux Disease |
University of Louisville |
2007-06 | PHASE4 |
| NCT00712413 | WITHDRAWN | Helicobacter Pylori Infection |
Forest Laboratories |
2008-08 | PHASE3 |
| NCT00164840 | COMPLETED | Gastroesophageal Reflux Disease |
Chinese University of Hong Kong |
2003-05 | PHASE3 |
| NCT00726726 | COMPLETED | Alzheimer Disease |
Bristol-Myers Squibb |
2008-08 | PHASE1 |
| NCT00749385 | COMPLETED | Arthritis |
POZEN |
2008-08 | PHASE1 |
| NCT00444275 | COMPLETED | GERD |
AstraZeneca |
2007-03 | PHASE4 |
| NCT00734097 | COMPLETED | Gastroesophageal Reflux Disease |
AstraZeneca |
2007-11 | PHASE4 |
| NCT02182336 | COMPLETED | Healthy |
Boehringer Ingelheim |
2008-06 | PHASE1 |
| NCT00287339 | COMPLETED | Cough; GERD |
University of North Carolina, Chapel Hill |
2005-09 | PHASE4 |
| NCT00692510 | COMPLETED | Metabolism; Alzheimer's Disease |
AstraZeneca |
2007-11 | PHASE1 |
| NCT00420615 | COMPLETED | Solid Tumors |
Novartis Pharmaceuticals |
2006-12 | PHASE1 |
| NCT00765206 | COMPLETED | Gastric Acid; Human Experimentation |
Bayer |
2008-05 | PHASE3 |
| NCT00441727 | COMPLETED | Gastric Ulcer; Duodenal Ulcer |
AstraZeneca |
2007-02 | PHASE3 |
| NCT00684190 | COMPLETED | Gastroesophageal Reflux Disease |
AstraZeneca |
2008-03 | PHASE1 |
| NCT00468559 | COMPLETED | Gastroesophageal Reflux Disease (GERD) |
AstraZeneca |
2007-04 | PHASE3 |
| NCT00520949 | COMPLETED | Treatment of Helicobacter Pylori |
Aga Khan University |
2006-10 | |
| NCT00069823 | COMPLETED | Asthma; Lung Diseases; Lung Diseases, Obstructive |
Johns Hopkins Bloomberg School of Public Health |
2003-09 | PHASE3 |
| NCT00464308 | COMPLETED | Gastro-oesophageal Reflux |
Janssen-Cilag Pty Ltd |
2006-11 | PHASE4 |
| NCT00688428 | COMPLETED | Ulcers; Upper GI Symptoms |
AstraZeneca |
2008-04 | PHASE1 |
| NCT00272467 | COMPLETED | Stomach Ulcer |
Korea Otsuka International Asia Arab |
2005-07 | PHASE4 |
| NCT01323465 | COMPLETED | Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Known Inducer of CYP3A4; Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Potent Inhibitor of CYP3A4; Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a CYP2C19 Inhibitor |
Jazz Pharmaceuticals |
2008-02 | PHASE1 |
| NCT00745849 | COMPLETED | Vasomotor Rhinitis |
University of Texas Southwestern Medical Center |
2005-06 | |
| NCT02141698 | COMPLETED | Dose Finding Study |
Takeda |
2007-10 | PHASE1 |
| NCT00632086 | COMPLETED | Healthy |
POZEN |
2008-02 | PHASE1 |
| NCT00222131 | COMPLETED | Indigestion |
University of Kansas Medical Center |
2003-10 | PHASE2 |
| NCT00332748 | TERMINATED | Cancer |
Bristol-Myers Squibb |
2006-12 | PHASE1 |
| NCT00251979 | COMPLETED | Gastrointestinal Hemorrhage |
AstraZeneca |
2005-10 | PHASE3 |
| NCT00557349 | COMPLETED | Marginal Ulcers |
University of Missouri-Columbia |
2006-11 | PHASE4 |
| NCT00426595 | COMPLETED | Gastreoesophageal Reflux Disease |
University Hospital, Ghent |
2007-04 | PHASE2 |
| NCT00519519 | COMPLETED | Bleeding Peptic Ulcers Disease |
Singapore General Hospital |
2004-07 | PHASE3 |
| NCT00222079 | TERMINATED | Gastro-esophageal Reflux |
Douglas Trask |
2004-11 | |
| NCT00225238 | COMPLETED | Nausea; Vomiting; Abdominal Pain |
Thomas Jefferson University |
2003-12 | PHASE4 |
| NCT00367211 | COMPLETED | Osteoarthritis; Rheumatoid Arthritis; Ankylosing Spondylitis |
POZEN |
2006-09 | PHASE3 |
| NCT00343161 | COMPLETED | Gastroesophageal Reflux Disease |
AstraZeneca |
2006-08 | PHASE4 |
| NCT00243724 | COMPLETED | Gastroesophageal Reflux; Heartburn; Dyspepsia |
AstraZeneca |
2005-04 | PHASE3 |
| NCT01061034 | COMPLETED | Aspirin Blood Level; Proton Pump Inhiditor Treatment |
Assaf-Harofeh Medical Center |
2007-03 | |
| NCT00384592 | COMPLETED | Gastro-Oesophageal Reflux Disease |
AstraZeneca |
2006-09 | PHASE4 |
| NCT00405119 | COMPLETED | Gastroesophageal Reflux Disease; Reflux, Gastroesophageal |
GlaxoSmithKline |
2006-05 | PHASE2 |
| NCT01045642 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2006-12 | PHASE1 |
| NCT00608712 | COMPLETED | Postoperative Bariatric Surgery |
AstraZeneca |
2005-11 | PHASE4 |
| NCT00325715 | COMPLETED | Peptic Ulcer |
Allergan |
2006-04 | PHASE1 |
| NCT02243553 | COMPLETED | Healthy |
Boehringer Ingelheim |
2006-01 | PHASE1 |
| NCT00590928 | COMPLETED | Critically Ill Patients; Indication for Stress Ulcer Prophylaxis |
Medical University of Vienna |
2004-07 | PHASE4 |
| NCT02253875 | COMPLETED | Healthy |
Boehringer Ingelheim |
2005-11 | PHASE1 |
| NCT03979989 | COMPLETED | Pharmacokinetic |
Grünenthal GmbH |
2005-09-28 | PHASE1 |
| NCT00256737 | COMPLETED | GERD |
AstraZeneca |
1998-01 | PHASE3 |
| NCT00953381 | COMPLETED | Duodenal Ulcer |
Livzon Pharmaceutical Group Inc. |
2004-10 | PHASE2 |
| NCT00625274 | COMPLETED | Heartburn; Upper Abdominal Pain; Nausea; Acid Regurgitation |
AstraZeneca |
2004-06 | PHASE4 |
| NCT00184522 | COMPLETED | Gastroesophageal Reflux |
Norwegian University of Science and Technology |
2002-08 | PHASE4 |
| NCT00259051 | COMPLETED | Non-erosive Reflux Disease |
AstraZeneca |
2004-01 | PHASE3 |
| NCT00259077 | COMPLETED | Non-erosive Reflux Disease |
AstraZeneca |
2003-10 | PHASE3 |
| NCT00628953 | COMPLETED | Asthma |
AstraZeneca |
2002-10 | PHASE2 |
| NCT00626535 | COMPLETED | Symptomatic Gastroesophageal Reflux Disease (sGERD) |
AstraZeneca |
2003-03 | PHASE3 |
| NCT00644735 | COMPLETED | Erosive Esophagitis |
AstraZeneca |
2002-12 | PHASE4 |
| NCT00641602 | COMPLETED | Erosive Esophagitis |
AstraZeneca |
2002-12 | PHASE4 |
| NCT00641264 | COMPLETED | Laryngopharyngeal Reflux (LPR) |
AstraZeneca |
2001-05 | PHASE4 |
| NCT00637559 | COMPLETED | Barrett's Esophagus |
AstraZeneca |
2002-03 | PHASE4 |
| NCT00629928 | COMPLETED | NSAID Associated Gastric Ulcers |
AstraZeneca |
2001-02 | PHASE3 |
| NCT00628667 | COMPLETED | Chronic Posterior Laryngitis (CPL) |
AstraZeneca |
2002-02 | PHASE4 |
| NCT00241553 | COMPLETED | NSAIDs; Upper GI Symptoms |
AstraZeneca |
2001-04 | PHASE3 |
| NCT00241514 | COMPLETED | GERD |
AstraZeneca |
2001-02 | PHASE3 |
| NCT00629512 | COMPLETED | NSAID Associated Gastric Ulcers |
AstraZeneca |
2001-03 | PHASE3 |
| NCT00629564 | COMPLETED | GERD |
AstraZeneca |
2002-09 | PHASE4 |
| NCT00626262 | COMPLETED | Gastroesophageal Reflux Disease |
AstraZeneca |
2002-07 | PHASE4 |
| NCT00241527 | COMPLETED | NSAIDs; Upper GI Symptoms |
AstraZeneca |
2000-12 | PHASE3 |
| NCT00241540 | COMPLETED | GERD |
AstraZeneca |
2001-01 | PHASE3 |
| NCT00002682 | COMPLETED | Lymphoma |
M.D. Anderson Cancer Center |
1995-08-10 | PHASE2 |
| NCT02518373 | COMPLETED | Colorectal Cancer |
Cancer Advances Inc. |
2000-04 | PHASE2 |
| NCT00003151 | COMPLETED | Lymphoma |
European Organisation for Research and Treatment of Cancer - EORTC |
1997-09 | PHASE2 |
| NCT00854451 | COMPLETED | Duodenal Ulcer; Helicobacter Pylori Infection |
National Taiwan University Hospital |
1996-08 | PHASE4 |
| NCT01599858 | COMPLETED | Reflux Oesophagitis |
Trio Medicines Ltd. |
1996-08 | PHASE1 |
| NCT00339768 | COMPLETED | Precancerous Gastric Lesions |
National Cancer Institute (NCI) |
1995-07-01 | PHASE3 |
| NCT00365313 | COMPLETED | Arthritis; Bleeding Ulcer |
Chinese University of Hong Kong |
2002-08 | PHASE3 |
| NCT00427635 | COMPLETED | GERD |
AstraZeneca |
2006-10 | PHASE3 |
| NCT00045799 | COMPLETED | Upper Gastrointestinal Bleeding |
Bausch Health Americas, Inc. |
2002-05 | PHASE3 |
| NCT01000220 | UNKNOWN | Glaucoma |
Shahid Beheshti University of Medical Sciences |
PHASE1 | |
| NCT00350155 | COMPLETED | Healthy Volunteers |
Novartis |
2006-05 | PHASE4 |
| NCT00216788 | UNKNOWN | Reflux; Esophagitis; Barrett's Esophagus |
Main Line Health |
2006-01 | PHASE1 |
| NCT01260844 | WITHDRAWN | Moderate to Severe Plaque Psoriasis |
Abbott |
2011-04 | PHASE1 |
| NCT00392002 | COMPLETED | Gastroesophageal Reflux |
AstraZeneca |
2005-10 | PHASE4 |
| NCT00542789 | COMPLETED | Gastric Ulcer; Duodenal Ulcer; Rheumatoid Arthritis; Osteoarthritis; Lumbago |
AstraZeneca |
2007-08 | PHASE3 |
| NCT00251966 | COMPLETED | Gastroesophageal Reflux |
AstraZeneca |
2004-05 | PHASE3 |
| NCT00930306 | COMPLETED | Chronic Pain |
AstraZeneca |
2009-06 | PHASE1 |
| NCT00164931 | COMPLETED | Peptic Ulcer Hemorrhage |
Chinese University of Hong Kong |
2003-10 | PHASE3 |
| NCT00443170 | COMPLETED | Healthy Subjects; Anaemia |
GlaxoSmithKline |
2006-11 | PHASE1 |
| NCT01015729 | TERMINATED | Peptic Ulcer Disease |
AstraZeneca |
2009-11 | PHASE1 |
| NCT00291746 | COMPLETED | Gastroesophageal Reflux |
AstraZeneca |
2005-09 | PHASE4 |
| NCT00994708 | COMPLETED | Airway Responsiveness |
Tampere University Hospital |
2004-12 | PHASE3 |
| NCT00471029 | UNKNOWN | Peptic Ulcer |
Pamela Youde Nethersole Eastern Hospital |
2005-09 | PHASE4 |
| NCT00352261 | COMPLETED | Barrett's Esophagus |
AstraZeneca |
2006-01 | PHASE4 |
| NCT00516971 | UNKNOWN | Gastroesophageal Reflux |
Hospital Authority, Hong Kong |
2003-01 | |
| NCT00455754 | UNKNOWN | Lymphocytic Gastritis |
Technische Universität Dresden |
2007-02 | PHASE3 |
| NCT01471925 | WITHDRAWN | Gastroesophageal Reflux Disease |
Eurofarma Laboratorios S.A. |
PHASE3 | |
| NCT00526006 | UNKNOWN | Healthy |
Zealand University Hospital |
2007-09 | PHASE4 |
| NCT00162877 | UNKNOWN | Peptic Ulcer With H. Pylori Infection; Gastritis With H. Pylori Infection |
National Taiwan University Hospital |
2004-06 | |
| NCT00272701 | COMPLETED | Gastroesophageal Reflux Disease |
AstraZeneca |
2005-12 | PHASE4 |
| NCT00426452 | COMPLETED | Healthy |
Novartis |
2006-07 | PHASE1 |
| NCT00241501 | COMPLETED | Gastroesophageal Reflux Disease (GERD) |
AstraZeneca |
2004-02 | PHASE3 |
| NCT00442052 | COMPLETED | Healthy |
POZEN |
2006-11 | PHASE1 |
| NCT00574925 | COMPLETED | Gastroesophageal Reflux Disease (GERD) |
University of Zurich |
2003-11 | PHASE4 |
| NCT00474019 | COMPLETED | Pharmacokinetics |
AstraZeneca |
2007-10 | PHASE1 |
| NCT00318968 | COMPLETED | GERD |
AstraZeneca |
2006-05 | PHASE4 |
| NCT00228527 | COMPLETED | Gastroesophageal Reflux Disease (GERD); Erosive Esophagitis; Non-erosive Esophagitis |
AstraZeneca |
2004-10 | PHASE4 |
| NCT00881413 | WITHDRAWN | Peptic Ulcer |
Lotung Poh-Ai Hospital |
PHASE4 | |
| NCT00349661 | COMPLETED | Coronary Heart Disease |
University Hospital, Brest |
2006-06 | PHASE3 |
| NCT00640809 | COMPLETED | Bowel Diseases, Inflammatory |
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
2003-10 | PHASE4 |
| NCT00363701 | UNKNOWN | Dyspepsia; Gastroesophageal Refluxdisease; Ulcer |
Glostrup University Hospital, Copenhagen |
2006-08 | PHASE4 |
| NCT00003617 | UNKNOWN | Gastric Cancer |
Lymphoma Trials Office |
1995-03 | PHASE3 |
| NCT00230516 | COMPLETED | Healthy |
AstraZeneca |
2005-09 | PHASE4 |
| NCT00633932 | COMPLETED | Reflux Esophagitis |
AstraZeneca |
2007-12 | PHASE3 |
| NCT00473980 | COMPLETED | Colorectal Cancer |
Göteborg University |
1998-12 | PHASE4 |
| NCT00318084 | COMPLETED | GERD |
AstraZeneca |
2003-01 | PHASE4 |
| NCT00164866 | COMPLETED | Peptic Ulcer |
Chinese University of Hong Kong |
2004-02 | PHASE4 |
(data from https://clinicaltrials.gov, updated on 2024-11-07)
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>).