Several clinical trials evaluate metoclopramide across therapeutic applications, including post-operative nausea and vomiting, upper gastrointestinal bleeding, diabetic gastroparesis, brain injuries, and surgical complications. Encompassing Phase 2, Phase 3, and phase Not Applicable studies, these trials are currently recruiting or of unknown status and investigate applications such as nausea prevention and endoscopic visualization. Research support is provided by diverse academic and industry sponsors, including Milton S. Hershey Medical Center, CinDome Pharma Inc., and Zagazig University.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05759481 | Recruiting | Post-operative Nausea and Vomiting |
Milton S. Hershey Medical Center |
2024-02-01 | Phase 2 |
| NCT06297954 | Recruiting | Upper Gastrointestinal Bleeding |
Universidad Autonoma de Nuevo Leon |
2023-03-16 | Phase 3 |
| NCT05832151 | Recruiting | Diabetic Gastroparesis |
CinDome Pharma Inc. |
2023-03-27 | Phase 2 |
| NCT05008926 | Recruiting | Brain Injuries |
University Hospital Brest |
2022-03-15 | Phase 3 |
| NCT04748133 | Unknown status | Treatment Complication |
Zagazig University |
2021-02-20 | Not Applicable |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
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>).