Lansoprazole has been evaluated in numerous clinical trials spanning Early Phase 1 through Phase 4, focusing on acid-related gastrointestinal conditions including gastroesophageal reflux disease, reflux esophagitis, gastric ulcers, and duodenal ulcers. Sponsored by industry leaders like Takeda and AstraZeneca as well as academic institutions, these studies assess pharmacokinetics, safety, and efficacy in healthy volunteers, pediatric populations, and premature infants. While predominantly completed, the overall clinical portfolio includes active, recruiting, terminated, and withdrawn studies, including Phase 3 trials for peptic esophagitis and ulcer recurrence.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07337655 | NOT_YET_RECRUITING | Pre-term Birth |
Stanford University |
2026-10-01 | PHASE2; PHASE3 |
| NCT07732075 | NOT_YET_RECRUITING | Maintenance of Healed Erosive Gastroesophageal Reflux Disease (ERD) |
Onconic Therapeutics Inc. |
2026-08-01 | PHASE3 |
| NCT07313774 | WITHDRAWN | GERD (Gastroesophageal Reflux Disease) |
Cinclus Pharma Holding AB |
2026-03 | PHASE3 |
| NCT07479056 | RECRUITING | Acute Coronary Syndromes (ACS); Coronary Artery Disease (CAD) |
SUK MIN SEO |
2024-10-24 | |
| NCT07730138 | NOT_YET_RECRUITING | Gastric Ulcer |
Daewoong Pharmaceutical Co. LTD. |
2026-10-15 | PHASE3 |
| NCT07533266 | NOT_YET_RECRUITING | NSAID (Non-Steroidal Anti-Inflammatory Drug) |
Daewoong Pharmaceutical Co. LTD. |
2026-04 | PHASE4 |
| NCT07708545 | RECRUITING | Peptic Ulcer Bleeding |
Indonesia University |
2026-08-06 | PHASE2 |
| NCT03675672 | RECRUITING | Active Peptic Ulcer Disease/GI Bleeding |
Chinese University of Hong Kong |
2018-06-21 | PHASE4 |
| NCT05926804 | RECRUITING | Helicobacter Pylori Infection |
Miguel O'Ryan Gallardo |
2022-08-02 | |
| NCT06284876 | RECRUITING | Peptic Ulcer |
Il-Yang Pharm. Co., Ltd. |
2024-07-23 | PHASE3 |
| NCT07037875 | ACTIVE_NOT_RECRUITING | GERD (Gastroesophageal Reflux Disease) |
Cinclus Pharma Holding AB |
2025-09-11 | PHASE3 |
| NCT02616302 | COMPLETED | Gastroesophageal Reflux Disease (GERD) |
Takeda |
2023-02-20 | PHASE2 |
| NCT06964334 | NOT_YET_RECRUITING | Helicobacter Pylori Infection |
Assiut University |
2025-06-01 | PHASE3 |
| NCT07344506 | RECRUITING | H. Pylori Gastrointestinal Disease; H.Pylori Infection; H.Pylori Eradication Rate |
Dow University of Health Sciences |
2025-05-01 | PHASE4 |
| NCT02615184 | TERMINATED | Erosive Esophagitis |
Takeda |
2023-05-23 | PHASE2 |
| NCT04965298 | RECRUITING | Idiopathic Pulmonary Fibrosis |
Norfolk and Norwich University Hospitals NHS Foundation Trust |
2021-06-16 | PHASE3 |
| NCT06894992 | RECRUITING | Peptic Ulcer Bleeding |
Mario Steffanus |
2025-05-01 | |
| NCT02442752 | WITHDRAWN | Pediatric Gastroesophageal Reflux Disease |
Takeda |
2025-06-15 | PHASE1 |
| NCT04713670 | RECRUITING | H. Pylori Infection |
National Taiwan University Hospital |
2021-03-10 | PHASE4 |
| NCT06931223 | NOT_YET_RECRUITING | Functioanl Dyspepsia |
RenJi Hospital |
2025-04-10 | |
| NCT05946135 | COMPLETED | Patients on Treatment With Systemic Steroids |
Yonsei University |
2023-11-07 | PHASE4 |
| NCT06945237 | COMPLETED | Gastroesophageal Reflux Disease |
RenJi Hospital |
2025-04-24 | |
| NCT02442752 | Withdrawn | Pediatric Gastroesophageal Reflux Disease |
Takeda |
2025-06-15 | Phase 1 |
| NCT04248335 | COMPLETED | Pediatric Obesity; NAFLD; GERD |
Children's Mercy Hospital Kansas City |
2018-07-03 | PHASE4 |
| NCT05933031 | UNKNOWN | Helicobacter Pylori Infection |
HK inno.N Corporation |
2023-02-27 | PHASE2 |
| NCT06778395 | COMPLETED | Vonoprazan; Proton Pump Inhibitor; Gastroesophageal Reflux Disease |
Ayman Magd Eldin Mohammad Sadek |
2024-10-01 | PHASE4 |
| NCT06156085 | COMPLETED | Helicobacter Pylori Infection |
Fu Jen Catholic University Hospital |
2023-11-14 | PHASE4 |
| NCT04188119 | WITHDRAWN | Breast Cancer |
The Christie NHS Foundation Trust |
2023-12-01 | PHASE2 |
| NCT05448001 | COMPLETED | Gastric Ulcer |
Onconic Therapeutics Inc. |
2022-09-19 | PHASE3 |
| NCT04840550 | UNKNOWN | Preventive Peptic Ulcer |
HK inno.N Corporation |
2021-05-07 | PHASE3 |
| NCT06025773 | COMPLETED | Gastro Esophageal Reflux |
Addpharma Inc. |
2023-09-15 | PHASE1 |
| NCT05820048 | UNKNOWN | Coronary Artery Disease |
Daejeon St. Mary's hospital |
2023-05-01 | PHASE4 |
| NCT03015610 | COMPLETED | Asthma; Gastroesophageal Reflux |
Jason Lang, M.D., M.P.H. |
2017-10-31 | PHASE3 |
| NCT04784910 | COMPLETED | Peptic Ulcer |
Daewoong Pharmaceutical Co. LTD. |
2021-05-21 | PHASE3 |
| NCT05711810 | COMPLETED | Severe Acute Respiratory Syndrome-related Coronavirus; Renal Dialysis; Vaccines; Myocarditis Allergic; Infection Viral |
Yang I. Pachankis |
2023-01-02 | PHASE4 |
| NCT04874935 | COMPLETED | Breast Cancer |
Tanta University |
2021-06-10 | PHASE3 |
| NCT04877834 | COMPLETED | Healthy; Bioequivalence Study |
University of Karachi |
2021-09-18 | PHASE1 |
| NCT05010954 | COMPLETED | Duodenal Ulcer |
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. |
2021-10-18 | PHASE3 |
| NCT05055128 | COMPLETED | Erosive Esophagitis |
Cinclus Pharma Holding AB |
2021-08-11 | PHASE2 |
| NCT03202537 | COMPLETED | Gastro Esophageal Reflux |
Northwestern University |
2017-07-01 | EARLY_PHASE1 |
| NCT07079540 | COMPLETED | Reflux Esophagitis |
Jiangsu Sinorda Biomedicine Co., Ltd |
2021-06-24 | PHASE3 |
| NCT05267743 | COMPLETED | Erosive Reflux Disease |
HK inno.N Corporation |
2021-02-16 | PHASE4 |
| NCT04423588 | WITHDRAWN | Bariatric Surgery |
Spital Limmattal Schlieren |
2022-01-01 | PHASE4 |
| NCT05259007 | UNKNOWN | Helicobacter Pylori Infection |
Fatma Zehra Arvas |
2022-02-22 | PHASE4 |
| NCT02679508 | COMPLETED | Erosive Esophagitis |
Takeda |
2016-03-20 | PHASE4 |
| NCT04674774 | UNKNOWN | Helicobacter Pylori Infection |
Incheon St.Mary's Hospital |
2021-03-04 | |
| NCT05184491 | UNKNOWN | Helicobacter Pylori |
National Liver Institute, Egypt |
2021-10-15 | PHASE4 |
| NCT05861687 | COMPLETED | Helicobacter Pylori Infection |
Finni Kollins |
2021-08-01 | PHASE2; PHASE3 |
| NCT05417997 | COMPLETED | COVID-19 Respiratory Infection; FLU; Cold; Influenza; Bacterial Pneumonia; COVID-19 Pneumonia |
RAAS Nutritionals, LLC |
2021-05-29 | PHASE3 |
| NCT04101708 | UNKNOWN | Helicobacter Pylori |
Shandong University |
2019-09-20 | PHASE4 |
| NCT05050188 | COMPLETED | Erosive Esophagitis |
Jiangsu Carephar Pharmaceutical Co., Ltd. |
2021-06-24 | PHASE1 |
| NCT04341428 | UNKNOWN | Healed Erosive Esophagitis |
Daewoong Pharmaceutical Co. LTD. |
2020-07-02 | PHASE3 |
| NCT04124926 | COMPLETED | Erosive Esophagitis |
Phathom Pharmaceuticals, Inc. |
2019-10-28 | PHASE3 |
| NCT04400136 | UNKNOWN | Gastro Esophageal Reflux; Barrett Esophagus; Bariatric Surgery Candidate |
University of Roma La Sapienza |
2020-07-01 | EARLY_PHASE1 |
| NCT03192059 | COMPLETED | Cervical Cancer; Endometrial Cancer; Uterine Cancer |
University Hospital, Ghent |
2017-07-01 | PHASE2 |
| NCT04660461 | UNKNOWN | Grönblad-Stranberg Disease (Pseudoxanthoma Elasticum) |
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud |
2020-02-04 | PHASE4 |
| NCT04022096 | COMPLETED | Healed Erosive Esophagitis |
HK inno.N Corporation |
2019-06-18 | PHASE3 |
| NCT04729101 | COMPLETED | Healthy Participants |
Phathom Pharmaceuticals, Inc. |
2021-01-28 | PHASE1 |
| NCT04167670 | COMPLETED | Helicobacter Pylori Infection |
Phathom Pharmaceuticals, Inc. |
2019-12-10 | PHASE3 |
| NCT03794596 | WITHDRAWN | Breast Cancer |
The Christie NHS Foundation Trust |
2019-09 | PHASE2 |
| NCT04531475 | COMPLETED | Reflux Esophagitis |
Jiangsu Sinorda Biomedicine Co., Ltd |
2020-01-21 | PHASE2 |
| NCT04453189 | COMPLETED | Healthy Participants |
Janssen Research & Development, LLC |
2020-07-20 | PHASE1 |
| NCT03050307 | COMPLETED | Gastric Ulcer |
Takeda |
2017-04-17 | PHASE3 |
| NCT03498456 | COMPLETED | Helicobacter Pylori Infection |
HK inno.N Corporation |
2018-06-28 | 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 | |
| NCT01180179 | COMPLETED | Peptic Ulcer |
Chinese University of Hong Kong |
2010-06 | PHASE4 |
| NCT03829150 | COMPLETED | Helicobacter Pylori Infection |
Chang Gung Memorial Hospital |
2017-03-01 | |
| NCT03710434 | COMPLETED | Healthy Volunteers |
AstraZeneca |
2018-11-01 | PHASE1 |
| NCT03050359 | COMPLETED | Duodenal Ulcer |
Takeda |
2017-04-05 | PHASE3 |
| NCT03801148 | COMPLETED | Healthy Volunteers |
Takeda |
2019-01-10 | PHASE1 |
| NCT03130452 | COMPLETED | Helicobacter Pylori Infection |
Inje University |
2016-12-17 | PHASE4 |
| NCT03487562 | COMPLETED | Healthy |
Daewoong Pharmaceutical Co. LTD. |
2018-04-08 | PHASE1 |
| NCT03524833 | COMPLETED | Helicobacter Pylori Infection |
Mackay Memorial Hospital |
2018-05-07 | PHASE4 |
| NCT02388737 | COMPLETED | Erosive Esophagitis |
Takeda |
2015-04-01 | PHASE3 |
| NCT03355170 | WITHDRAWN | GERD; Cardiac Event; Safety Issues |
Neutec Ar-Ge San ve Tic A.Ş |
2018-03-01 | PHASE4 |
| NCT03488186 | COMPLETED | Effect of Drugs; Safety Issues |
First Affiliated Hospital of Zhejiang University |
2018-07-19 | PHASE1 |
| NCT02761512 | COMPLETED | Gastric Ulcer |
HK inno.N Corporation |
2016-05 | PHASE3 |
| NCT03488173 | COMPLETED | Effect of Drugs; Safety Issues |
First Affiliated Hospital of Zhejiang University |
2018-04-23 | PHASE1 |
| NCT03468777 | TERMINATED | Healthy |
Janssen Research & Development, LLC |
2018-03-06 | PHASE1 |
| NCT03418337 | UNKNOWN | Compare the Response Rate of Atypical GERD After PPI Therapy |
Taipei Veterans General Hospital, Taiwan |
2017-08-01 | |
| NCT03273634 | COMPLETED | Arrhythmia |
Jordan Collaborating Cardiology Group |
2017-05-20 | PHASE4 |
| NCT02873689 | COMPLETED | Heartburn; Gastroesophageal Reflux Disease |
Takeda |
2016-12-27 | PHASE3 |
| NCT03316976 | COMPLETED | Healthy Volunteers |
Takeda |
2017-11-22 | PHASE1 |
| NCT03124420 | COMPLETED | Helicobacter Pylori Infection |
Mackay Memorial Hospital |
2017-04-28 | PHASE4 |
| NCT03087162 | COMPLETED | H Pylori Eradication |
Ramathibodi Hospital |
2017-01-01 | PHASE4 |
| NCT02388581 | UNKNOWN | Gastric Diffuse Large B-cell Lymphoma |
National Health Research Institutes, Taiwan |
2014-12 | PHASE2 |
| NCT03316976 | Completed | Healthy Volunteers |
Takeda |
2017-11-22 | Phase 1 |
| NCT01506986 | COMPLETED | Gastrointestinal Ulcer Haemorrhage; Bacterial Infection Due to Helicobacter Pylori (H. Pylori) |
University of Nottingham |
2012-03 | PHASE4 |
| NCT02873702 | TERMINATED | Erosive Esophagitis |
Takeda |
2016-12-21 | PHASE3 |
| NCT03120273 | UNKNOWN | Effect of Drugs; Safety Issues |
First Affiliated Hospital of Zhejiang University |
2017-05-05 | PHASE1 |
| NCT02530879 | WITHDRAWN | Laryngopharyngeal Reflux |
Temple University |
2016-05 | PHASE4 |
| NCT03079050 | COMPLETED | GERD; Proton Pump Inhibitor |
American University of Beirut Medical Center |
2017-02-27 | PHASE4 |
| NCT02388724 | COMPLETED | Erosive Esophagitis |
Takeda |
2015-03-24 | PHASE3 |
| NCT03131895 | COMPLETED | Healthy Volunteers |
Takeda |
2017-04-25 | PHASE1 |
| NCT02759393 | UNKNOWN | Gastroesophageal Reflux Disease |
National Cheng-Kung University Hospital |
2015-10 | PHASE4 |
| NCT03059303 | TERMINATED | Healthy |
Janssen Research & Development, LLC |
2017-02-20 | PHASE1 |
| NCT02892409 | COMPLETED | Helicobacter Pylori |
Takeda |
2016-09-05 | PHASE1 |
| NCT03011125 | COMPLETED | Safety Issues |
First Affiliated Hospital of Zhejiang University |
2017-01 | PHASE1 |
| NCT02351960 | COMPLETED | Gastroesophageal Reflux Disease |
Takeda |
2015-03-19 | PHASE4 |
| NCT02633930 | COMPLETED | Gastritis; Peptic Ulcer; Dyspepsia |
Xijing Hospital of Digestive Diseases |
2015-12 | PHASE4 |
| NCT02625259 | COMPLETED | Neoplasm, Advanced or Metastatic |
Millennium Pharmaceuticals, Inc. |
2016-01-08 | PHASE1 |
| NCT02162758 | TERMINATED | Barrett's Esophagus |
Takeda |
2014-07 | PHASE2 |
| NCT03128736 | COMPLETED | Gastroesophageal Reflux Disease |
Kaohsiung Medical University Chung-Ho Memorial Hospital |
2014-04-01 | PHASE4 |
| NCT02755753 | COMPLETED | Gastroesophageal Reflux |
YongChan Lee |
2014-01 | PHASE4 |
| NCT02278081 | UNKNOWN | Rhinitis; Nasal Obstruction; GERD |
McGill University Health Centre/Research Institute of the McGill University Health Centre |
2015-01 | PHASE4 |
| NCT02490449 | UNKNOWN | Nonerosive Reflux Disease |
Soonchunhyang University Hospital |
2014-12 | |
| NCT02139046 | COMPLETED | Gout |
Takeda |
2014-04 | PHASE3 |
| NCT02175927 | COMPLETED | Helicobacter Pylori Treatment Failure |
Shanghai Jiao Tong University School of Medicine |
2014-07 | PHASE4 |
| NCT02128490 | COMPLETED | Gout; Moderate Renal Impairment |
Takeda |
2014-05 | PHASE2 |
| NCT01762657 | WITHDRAWN | Type 1 Diabetes |
Perle Bioscience, Inc. |
2014-09 | PHASE3 |
| NCT03043521 | COMPLETED | Healthy |
HK inno.N Corporation |
2015-05-13 | PHASE1 |
| NCT02541786 | COMPLETED | Helicobacter Pylori Infection |
Kaohsiung Medical University |
2015-01 | PHASE4 |
| NCT02958046 | COMPLETED | Gastroesophageal Reflux Disease |
Neutec Ar-Ge San ve Tic A.Ş |
2014-01 | PHASE4 |
| NCT01279252 | COMPLETED | Chronic Lymphocytic Leukaemia (CLL) |
King's College Hospital NHS Trust |
2011-07 | PHASE2 |
| NCT02175901 | COMPLETED | Dyspepsia; Peptic Ulcer |
Shanghai Jiao Tong University School of Medicine |
2014-07 | PHASE4 |
| NCT01481844 | COMPLETED | Optimization of Second Line Treatment Protocol for H Pylori Eradication |
Soroka University Medical Center |
2011-11 | PHASE3 |
| NCT00928161 | WITHDRAWN | Head and Neck Cancer; Oropharyngeal Cancer; Gastroesophageal Reflux Disease |
M.D. Anderson Cancer Center |
2012-11 | |
| NCT01093755 | COMPLETED | Inflammation; Barrett's Esophagus |
Mayo Clinic |
2010-03 | PHASE4 |
| NCT01642615 | COMPLETED | Gastroesophageal Reflux Disease; Erosive Esophagitis |
Takeda |
2012-07 | PHASE2 |
| NCT02334501 | COMPLETED | Healthy |
Puma Biotechnology, Inc. |
2014-08 | PHASE1 |
| NCT01216293 | COMPLETED | Homeostasis; Bone and Bones |
Takeda |
2010-11-01 | PHASE1 |
| NCT01946971 | COMPLETED | Premature Infants; Gastroesophageal Reflux |
Seoul National University Hospital |
2013-09 | PHASE1; PHASE2 |
| NCT01082029 | COMPLETED | Otitis Media With Effusion |
Hamilton Health Sciences Corporation |
2010-03 | PHASE4 |
| NCT01155284 | COMPLETED | Type 1 Diabetes |
Sanford Health |
2010-08 | PHASE2 |
| NCT02022280 | COMPLETED | Endothelial Dysfunction |
Stanford University |
2013-03 | PHASE1 |
| NCT02064907 | COMPLETED | Bioavailability |
Takeda |
2014-02 | PHASE1 |
| NCT02096458 | COMPLETED | Gastroesophageal Reflux Disease; Erosive Esophagitis; Heartburn |
Takeda |
2014-02 | PHASE1 |
| NCT01642602 | COMPLETED | Gastroesophageal Reflux Disease |
Takeda |
2012-07 | PHASE2 |
| NCT01607918 | UNKNOWN | Eradication Rates of the Two Regimens |
National Taiwan University Hospital |
2012-02 | PHASE4 |
| NCT01040455 | TERMINATED | Functional Dyspepsia |
National Taiwan University Hospital |
2009-12 | PHASE4 |
| NCT01317472 | TERMINATED | Laryngopharyngeal Reflux |
Indiana University |
2011-03 | |
| NCT01456247 | COMPLETED | Gastric Ulcers; Duodenal Ulcers |
Takeda |
2012-03 | PHASE3 |
| NCT01182597 | UNKNOWN | Peptic Ulcers |
National Taiwan University Hospital |
2010-08 | PHASE3 |
| NCT01505127 | COMPLETED | H. Pylori Infection |
Takeda |
2012-01 | PHASE3 |
| NCT01452750 | COMPLETED | Gastric Ulcers; Duodenal Ulcers |
Takeda |
2011-10 | PHASE3 |
| NCT01778101 | COMPLETED | Preterm Infants; Gastrointestinal Reflux |
Seoul National University Hospital |
2013-01 | PHASE2 |
| NCT01820104 | COMPLETED | Healthy |
Xijing Hospital |
2013-03 | PHASE1 |
| NCT01452763 | COMPLETED | Gastric Ulcers; Duodenal Ulcers |
Takeda |
2011-10 | PHASE3 |
| NCT01459367 | COMPLETED | Erosive Esophagitis |
Takeda |
2011-10 | PHASE3 |
| NCT01452724 | COMPLETED | Duodenal Ulcer |
Takeda |
2011-10 | PHASE3 |
| NCT02529787 | COMPLETED | Healthy |
Genuine Research Center, Egypt |
2013-02 | PHASE1 |
| NCT01452711 | COMPLETED | Gastric Ulcer |
Takeda |
2011-11 | PHASE3 |
| NCT01681186 | COMPLETED | Healthy Participants |
Eli Lilly and Company |
2012-09 | PHASE1 |
| NCT01667718 | COMPLETED | Functional Dyspepsia; Peptic Ulcer |
Shanghai Jiao Tong University School of Medicine |
2012-05 | PHASE4 |
| NCT01328652 | UNKNOWN | Laryngopharyngeal Reflux; Hypertrophy of Lingual Tonsil |
Advanced Center for Specialty Care |
2011-06 | PHASE4 |
| NCT01452698 | COMPLETED | Erosive Esophagitis |
Takeda |
PHASE3 | |
| NCT01512953 | UNKNOWN | Coronary Stenting |
Università degli Studi di Ferrara |
2011-01 | PHASE4 |
| NCT01175200 | COMPLETED | Anti Platelet Effects |
Ascopharm Groupe Novasco |
2010-09 | |
| NCT01328392 | WITHDRAWN | Laryngo-pharyngeal Reflux |
University of Washington |
2011-05 | |
| NCT01149395 | COMPLETED | Heartburn; Gastroesophageal Reflux Disease |
University of North Carolina, Chapel Hill |
2010-06 | PHASE1 |
| NCT01123031 | WITHDRAWN | Upper Gastrointestinal Bleeding |
Changhua Christian Hospital |
2010-04 | PHASE4 |
| NCT01479231 | WITHDRAWN | Gastroesophageal Reflux Disease; Eosinophilic Esophagitis; Dysphagia |
Mayo Clinic |
2012-03 | PHASE1; PHASE2 |
| NCT00708149 | COMPLETED | Respiratory Failure |
Far Eastern Memorial Hospital |
2009-06 | PHASE4 |
| NCT01216267 | COMPLETED | Neuroendocrine Carcinoma (Carcinoid) |
University of Western Ontario, Canada |
2010-06 | |
| NCT01131026 | COMPLETED | Helicobacter Pylori Infection |
Deva Holding A.S. |
2010-06 | PHASE3 |
| NCT01509261 | COMPLETED | Erosive Esophagitis; GERD |
Il-Yang Pharm. Co., Ltd. |
2010-07 | PHASE3 |
| NCT01147588 | COMPLETED | Healthy |
AstraZeneca |
2010-05 | PHASE1 |
| NCT00442013 | COMPLETED | Asthma |
Johns Hopkins University |
2007-03 | PHASE4 |
| NCT00837759 | TERMINATED | Diabetes Mellitus Type 1; Autoimmune Diabetes |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2009-02 | PHASE2 |
| NCT01039558 | COMPLETED | Gastroesophageal Reflux Disease |
Seoul National University Hospital |
2009-12 | |
| NCT00472186 | TERMINATED | Post-tonsillectomy Pain; Post-tonsillectomy Activity; Post-tonsillectomy Hydration |
Boston Children's Hospital |
2008-06 | PHASE4 |
| NCT01045096 | COMPLETED | Gastroesophageal Reflux |
Takeda |
2010-03 | PHASE1 |
| NCT00204373 | COMPLETED | Zollinger-Ellison Syndrome; Multiple Endocrine Neoplasia |
Charles Mel Wilcox, MD |
2003-03 | PHASE4 |
| NCT00854776 | UNKNOWN | Peptic Ulcer; Ulcer Complications |
Taipei Veterans General Hospital, Taiwan |
2009-01 | |
| NCT00523367 | TERMINATED | Gastroesophageal Reflux; Chronic Obstructive Pulmonary Disease |
University of Florida |
2007-08 | |
| NCT00926809 | UNKNOWN | Ulcer |
Korean College of Helicobacter and Upper Gastrointestinal Research |
2008-09 | PHASE4 |
| NCT00942175 | COMPLETED | Healthy |
Takeda |
2009-12 | PHASE1 |
| NCT01404832 | TERMINATED | Gastroesophageal Reflux Disease; Eosinophilic Esophagitis |
Dallas VA Medical Center |
2007-10 | PHASE4 |
| NCT00847808 | COMPLETED | Gastroesophageal Reflux |
Takeda |
2009-02 | PHASE3 |
| NCT01037452 | COMPLETED | Heartburn |
Novartis |
2009-12 | PHASE2 |
| NCT00237068 | UNKNOWN | Asthma |
Emory University |
2006-03 | PHASE4 |
| NCT00546117 | COMPLETED | Otitis Media With Effusion |
Washington University School of Medicine |
2007-10 | |
| NCT00673972 | WITHDRAWN | Functional Dyspepsia; Epigastric Pain Syndrome; Post Prandial Distress Syndrome |
National Taiwan University Hospital |
2008-04 | PHASE4 |
| NCT00369265 | TERMINATED | Laryngopharyngeal Reflux |
American Institute for Voice and Ear Research |
2006-08 | PHASE4 |
| NCT00825630 | COMPLETED | Helicobacter Pylori Infection |
Meridian Bioscience, Inc. |
2008-11 | PHASE4 |
| NCT00952913 | COMPLETED | Healthy |
Wyeth is now a wholly owned subsidiary of Pfizer |
2009-08 | PHASE1 |
| NCT00847210 | COMPLETED | Gastroesophageal Reflux |
Takeda |
2009-05 | PHASE1 |
| NCT00637416 | TERMINATED | Dysphonia |
University of Kansas Medical Center |
2008-03 | PHASE4 |
| NCT00663897 | COMPLETED | Functional Dyspepsia; Epigastric Pain Syndrome; Post Prandial Distress Syndrome |
Lotung Poh-Ai Hospital |
2008-05 | PHASE4 |
| NCT00787254 | COMPLETED | Stomach Ulcer; Duodenal Ulcer |
Takeda |
2007-04 | PHASE3 |
| NCT00361972 | TERMINATED | Gastroesophageal Reflux; Asthma |
University of Utah |
2006-08 | PHASE2; PHASE3 |
| NCT00627016 | COMPLETED | Gastroesophageal Reflux |
Takeda |
2008-03 | PHASE3 |
| NCT00685295 | COMPLETED | Pain, Fracture, Sprain |
Massachusetts General Hospital |
2008-08 | PHASE1; PHASE2 |
| NCT00983034 | COMPLETED | Nephrotic Syndrome; Glomerulonephritis; Membranous Nephropathy |
Istanbul University |
2006-03 | |
| NCT00335283 | COMPLETED | Larynx Disease |
Vanderbilt University |
2006-08 | PHASE3 |
| NCT01270308 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2008-12 | PHASE1 |
| NCT00762359 | TERMINATED | Stomach Ulcer; Duodenal Ulcer |
Takeda |
2007-05 | PHASE3 |
| NCT01135368 | COMPLETED | Gastroesophageal Reflux |
Takeda |
2002-06 | PHASE4 |
| NCT00215787 | COMPLETED | Nasal Polyps; Gastroesophageal Reflux |
Head and Neck Surgery Associates |
2005-09 | |
| NCT00467571 | COMPLETED | Chronic Idiopathic Thrombocytopenic Purpura; Helicobacter Pylori Infection |
Mahidol University |
2006-03 | PHASE4 |
| NCT01008696 | COMPLETED | Reflux Esophagitis |
Janssen Korea, Ltd., Korea |
2007-05 | PHASE4 |
| NCT00255190 | COMPLETED | Gastroesophageal Reflux Disease |
Takeda |
2006-01 | PHASE3 |
| NCT00471094 | COMPLETED | Esophagitis |
Takeda |
2007-05 | PHASE2 |
| NCT00321737 | COMPLETED | Esophagitis, Reflux; Esophagitis, Peptic |
Takeda |
2006-05 | PHASE3 |
| NCT00324974 | COMPLETED | Gastroesophageal Reflux Disease |
Takeda |
2006-06 | PHASE3 |
| NCT00458614 | COMPLETED | Cystic Fibrosis |
Arkansas Children's Hospital Research Institute |
2006-06 | PHASE1 |
| NCT00251719 | COMPLETED | Esophagitis, Reflux; Esophagitis, Peptic |
Takeda |
2005-12 | PHASE3 |
| NCT00251693 | COMPLETED | Esophagitis, Reflux; Esophagitis, Peptic |
Takeda |
2005-12 | PHASE3 |
| NCT00321984 | COMPLETED | Gastroesophageal Reflux Disease |
Takeda |
2006-06 | PHASE3 |
| NCT00255151 | COMPLETED | Esophagitis, Reflux; Esophagitis, Peptic |
Takeda |
2006-01 | PHASE3 |
| NCT00255164 | COMPLETED | Esophagitis, Reflux; Esophagitis, Peptic |
Takeda |
2006-01 | PHASE3 |
| NCT00211614 | WITHDRAWN | Obstructive Sleep Apnea; Gastroesophageal Reflux |
MetroHealth Medical Center |
2006-07 | |
| NCT00251745 | COMPLETED | Gastroesophageal Reflux Disease |
Takeda |
2005-12 | PHASE3 |
| NCT00251758 | COMPLETED | Gastroesophageal Reflux Disease |
Takeda |
2005-12 | PHASE3 |
| NCT00174928 | COMPLETED | Gastroesophageal Reflux Disease |
Takeda |
2005-05 | PHASE1 |
| NCT00220818 | COMPLETED | Gastroesophageal Reflux Disease |
Takeda |
2005-01 | PHASE1 |
| NCT00625274 | COMPLETED | Heartburn; Upper Abdominal Pain; Nausea; Acid Regurgitation |
AstraZeneca |
2004-06 | PHASE4 |
| NCT00175032 | COMPLETED | Osteoarthritis; Peptic Ulcer |
Takeda |
2003-07 | PHASE3 |
| NCT01045967 | COMPLETED | Healthy |
Teva Pharmaceuticals USA |
2004-05 | PHASE1 |
| NCT01046253 | COMPLETED | Healthy |
Teva Pharmaceuticals USA |
2004-01 | PHASE1 |
| NCT00644735 | COMPLETED | Erosive Esophagitis |
AstraZeneca |
2002-12 | PHASE4 |
| NCT00175045 | COMPLETED | Esophagitis; Reflux |
Takeda |
2003-06 | PHASE2 |
| NCT01046084 | COMPLETED | Healthy |
Teva Pharmaceuticals USA |
2003-08 | PHASE1 |
| NCT00641602 | COMPLETED | Erosive Esophagitis |
AstraZeneca |
2002-12 | PHASE4 |
| NCT00637845 | COMPLETED | Heartburn; Gastroesophageal Reflux Disease |
AstraZeneca |
2002-06 | PHASE4 |
| NCT02251184 | COMPLETED | Healthy |
Boehringer Ingelheim |
2000-10 | PHASE4 |
| NCT00299845 | WITHDRAWN | Gastroesophageal Reflux |
Osaka University |
PHASE4 | |
| NCT00149084 | UNKNOWN | Helicobacter Infections; Gastritis; Gastric Ulcer; Duodenal Ulcer |
Hamamatsu University |
2003-04 | PHASE3 |
| NCT00410592 | COMPLETED | Gastroesophageal Reflux Disease |
AstraZeneca |
2006-10 | PHASE4 |
| NCT00281047 | UNKNOWN | Helicobacter Pylori |
Hamamatsu University |
2006-01 | PHASE2; PHASE3 |
| NCT00701259 | COMPLETED | Frequent Heartburn |
Novartis |
2007-01 | PHASE3 |
| NCT00230516 | COMPLETED | Healthy |
AstraZeneca |
2005-09 | PHASE4 |
| NCT00573924 | COMPLETED | Peptic Ulcer Hemorrhage |
University of Southern California |
2006-02 | |
| NCT01456260 | COMPLETED | Gastric Ulcers; Duodenal Ulcers |
Takeda |
2011-09 | PHASE3 |
| NCT00390390 | COMPLETED | Heartburn |
Novartis |
2006-06 | PHASE3 |
| NCT00295685 | COMPLETED | GERD |
Digestive & Liver Disease Specialists |
2005-10 | PHASE4 |
| NCT00352261 | COMPLETED | Barrett's Esophagus |
AstraZeneca |
2006-01 | PHASE4 |
| NCT00220909 | TERMINATED | Patients Undergoing Elective Coronary Artery Bypass Graft |
Temple University |
2005-09 | PHASE4 |
| NCT00389948 | COMPLETED | Heartburn |
Novartis |
2006-06 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-01-13)
Check the
Lansoprazole
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
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>).
Note: Technical data last updated: Sep 1, 2026.