Clinical Trials

Multiple clinical trials are currently investigating interventions for conditions such as post-operative nausea and vomiting, acute upper gastrointestinal bleeding, diabetic gastroparesis, brain injuries, and surgical treatment complications. Encompassing Phase 2, Phase 3, and non-applicable phase designs, these actively recruiting and unknown-status studies evaluate targeted outcomes including post-operative emesis prevention and endoscopic clarity. These initiatives are sponsored by a range of academic institutions, hospital systems, and industry partners.

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)

Check the Metoclopramide HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Metoclopramide HCl selectively binds to and antagonizes dopamine D2 receptors in the chemoreceptor trigger zone and gastrointestinal tract, thereby blocking dopamine-mediated inhibition of smooth muscle motility and enhancing upper gastrointestinal cholinergic signaling. This inhibition promotes gastric emptying, increases lower esophageal sphincter tone, and suppresses emetic signal transduction, providing therapeutic efficacy in managing post-operative nausea and vomiting, endoscopic visualization in upper gastrointestinal bleeding, and diabetic gastroparesis.

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.