Clinical Trials
Numerous clinical trials across all trial phases have evaluated domperidone for gastrointestinal and neurological conditions, including gastroparesis, gastroesophageal reflux disease, low milk supply, secondary progressive multiple sclerosis, and sudden cardiac death risk. Sponsored by academic institutions—such as Assistance Publique - Hopitaux de Paris, Sunnybrook Health Sciences Centre, and the University of Calgary—and industry entities like Janssen Research & Development LLC, trial recruitment statuses range from active and completed to terminated or withdrawn. Key investigations include a clinical trial evaluating lactation enhancement and a clinical trial assessing preoperative gastric residual volume.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04699591 | RECRUITING | GERD; Gastroesophageal Reflux; Gastroparesis |
Jose Cocjin |
2013-04 | |
| NCT06695962 | NOT_YET_RECRUITING | Type 1 Diabetic |
University Hospital, Rouen |
2026-03-01 | PHASE3 |
| NCT01696734 | RECRUITING | Digestive System Disorder; Dyspepsia; Esophagitis; Gastroesophageal Reflux Disease; Gastroparesis; Heartburn; Nausea and Vomiting |
M.D. Anderson Cancer Center |
2012-10-23 | PHASE3 |
| NCT07578402 | NOT_YET_RECRUITING | Dyspepsia; Functioanl Dyspepsia; Epigastric Pain Syndrome; Epigastric Fullness |
Rakibul Mostafa |
2026-05-15 | PHASE4 |
| NCT06590805 | RECRUITING | Physical Therapy; Electrotherapy; Dietary Modification |
Haytham Ibrahim Morsi |
2024-09-01 | |
| NCT05570292 | COMPLETED | Gastric Residual Volume |
Ain Shams University |
2022-10-10 | PHASE3 |
| NCT05596006 | COMPLETED | Breastfeeding Mothers |
Gadjah Mada University |
2022-12-31 | PHASE2 |
| NCT04104867 | UNKNOWN | Abdominal Pain |
Mahidol University |
2019-09-16 | |
| NCT05570292 | Completed | Gastric Residual Volume |
Ain Shams University |
2022-10-10 | Phase 3 |
| NCT04583111 | UNKNOWN | Bowel Preparation |
RenJi Hospital |
2020-03-01 | PHASE4 |
| NCT04802785 | UNKNOWN | Air Travel |
Dinara Zhumanbayeva |
2021-06 | PHASE2; PHASE3 |
| NCT05076461 | COMPLETED | Vomiting in Infants and/or Children; Acute Gastroenteritis |
Tehsil Headquarter Hospital |
2020-07-01 | |
| NCT04653584 | Terminated | Parkinson Disease |
Assistance Publique - Hôpitaux de Paris |
2021-01-01 | -- |
| NCT03617016 | COMPLETED | Dyspepsia |
Xian-Janssen Pharmaceutical Ltd. |
2018-08-27 | PHASE4 |
| NCT05030116 | COMPLETED | Dyspepsia |
Ruijin Hospital |
2019-06-26 | PHASE4 |
| NCT02308137 | COMPLETED | Multiple Sclerosis, Secondary Progressive |
University of Calgary |
2015-02 | PHASE2 |
| NCT02493049 | COMPLETED | Multiple Sclerosis, Relapsing-Remitting |
University of Calgary |
2015-08 | PHASE2 |
| NCT03806062 | COMPLETED | Insufficient Lactation |
Cairo University |
2018-01-02 | PHASE4 |
| NCT03355170 | WITHDRAWN | GERD; Cardiac Event; Safety Issues |
Neutec Ar-Ge San ve Tic A.Ş |
2018-03-01 | PHASE4 |
| NCT03662113 | COMPLETED | Capsule Endoscopy; Pediatric Disorder |
Children's Hospital of Fudan University |
2017-11-01 | |
| NCT03837067 | Completed | Parkinson''s Disease |
Assistance Publique - Hôpitaux de Paris |
2018-07-17 | -- |
| NCT02699385 | TERMINATED | Gastroenteritis |
Janssen-Cilag International NV |
2015-12-07 | PHASE3 |
| NCT02980250 | COMPLETED | Feeding Intolerance; Premature Birth; Domperidone Overdose; Gastric Retention |
Nanfang Hospital, Southern Medical University |
2015-11 | PHASE4 |
| NCT00777439 | UNKNOWN | Gastroparesis |
Arnold, George, M.D. |
2008-10 | |
| NCT02816853 | COMPLETED | Healthy |
Janssen Research & Development, LLC |
2016-05 | PHASE1 |
| NCT03022201 | COMPLETED | Parkinson's Disease,Idiopathic |
Seoul National University Hospital |
2013-05 | PHASE4 |
| NCT03221855 | COMPLETED | Breastfeeding |
Hospital de Clinicas de Porto Alegre |
2013-03 | EARLY_PHASE1 |
| NCT01512225 | COMPLETED | Low Milk Supply |
Sunnybrook Health Sciences Centre |
2012-05 | PHASE2 |
| NCT02264587 | UNKNOWN | Diabetic Gastroparesis |
Liangzhou Wei |
2014-10 | PHASE4 |
| NCT01878526 | COMPLETED | Gastroesophageal Reflux Disease; Systemic Sclerosis; Scleroderma |
Khon Kaen University |
2013-06 | PHASE3 |
| NCT02685436 | COMPLETED | Gastroesophageal Reflux Disease |
Mansoura University Children Hospital |
2013-03 | PHASE4 |
| NCT02958046 | COMPLETED | Gastroesophageal Reflux Disease |
Neutec Ar-Ge San ve Tic A.Ş |
2014-01 | PHASE4 |
| NCT01844622 | COMPLETED | Digestive System Disease |
Mt. Sinai Medical Center, Miami |
2007-12 | |
| NCT02140073 | UNKNOWN | GERD |
Belarusian Medical Academy of Post-Graduate Education |
2013-12 | PHASE4 |
| NCT01711918 | COMPLETED | Patients With Gastroparesis Who Have Failed Standard Therapy |
Ron Schey |
2012-07 | |
| NCT01780909 | UNKNOWN | Concentration-Time Profiles in Stomach & Intestine. |
KU Leuven |
2013-02 | |
| NCT01257672 | COMPLETED | Gastroenteritis; Vomiting; Acute Gastroenteritis |
IRCCS Burlo Garofolo |
2011-07 | PHASE3 |
| NCT01710462 | Withdrawn | Gastroesophageal Reflux Disease |
Eurofarma Laboratorios S.A. |
2013-08 | Phase 3 |
| NCT01643889 | COMPLETED | Healthy |
Janssen Research & Development, LLC |
2012-07 | PHASE1 |
| NCT00761254 | TERMINATED | Gastroparesis; GERD; Esophagitis; Dyspepsia; Chronic Idiopathic Constipation; Nausea; Vomiting |
Carle Physician Group |
2008-08 | |
| NCT01378884 | WITHDRAWN | Gastroparesis |
Allegiance Health |
2010-03 | PHASE3 |
| NCT01907633 | Completed | Death Sudden Cardiac |
Janssen Research & Development LLC |
2011-12 | -- |
| NCT00760461 | TERMINATED | Gastroparesis |
Yale University |
2008-10 | PHASE2 |
| NCT01355276 | COMPLETED | Dyspepsia |
Eisai China Inc. |
2010-10 | PHASE3 |
| NCT01021475 | UNKNOWN | Functional Dyspepsia |
International College of Osteopathic Medicine |
2009-11 | PHASE1 |
| NCT00604942 | TERMINATED | Achalasia; GORD |
Guy's and St Thomas' NHS Foundation Trust |
2007-11 | |
| NCT00552422 | TERMINATED | Gastroparesis; Gastroesophageal Reflux |
David J. Lederer, M.D. |
2007-03 | |
| NCT01347814 | COMPLETED | Diabetes Mellitus |
University of Limerick |
2008-02 | |
| NCT00305331 | TERMINATED | Parkinson's Disease; Peripheral Edema |
University Health Network, Toronto |
2006-03 | PHASE2 |
| NCT00308334 | COMPLETED | Low Breast Milk Supply |
IWK Health Centre |
2003-10 | PHASE2; PHASE3 |
| NCT01710462 | WITHDRAWN | Gastroesophageal Reflux Disease |
Eurofarma Laboratorios S.A. |
2013-08 | PHASE3 |
| NCT00284024 | TERMINATED | Insufficient Breastmilk Production |
Hamilton Health Sciences Corporation |
2006-09 | PHASE2 |
| NCT00006077 | COMPLETED | Parkinson's Disease |
National Institute of Neurological Disorders and Stroke (NINDS) |
2000-08 | PHASE2 |
| NCT00238056 | COMPLETED | Prematurity and Feeding Intolerance |
Nantes University Hospital |
PHASE2 | |
| NCT00103597 | COMPLETED | Parkinson's Disease; Multiple System Atrophy; Orthostatic Hypotension |
Royal Brisbane and Women's Hospital |
2005-01 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-03-24)
Check the
Domperidone
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Compliance for Clinical Use
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>).
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Note: Technical data last updated: Sep 1, 2026.