Clinical Trials

Multiple clinical trials evaluate therapeutic protocols involving metoclopramide hydrochloride hydrate for managing post-operative nausea and vomiting, upper gastrointestinal bleeding, diabetic gastroparesis, brain injuries, and treatment complications. Spanning Phase 2, Phase 3, and non-phase designs, these studies currently report recruitment statuses as recruiting or unknown. Research sponsors encompass academic medical centers, health organizations, and pharmaceutical entities, including CinDome Pharma Inc.

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 hydrochloride hydrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Metoclopramide hydrochloride hydrate functions primarily as a dopamine D2 receptor antagonist with secondary 5-HT3 receptor antagonist and 5-HT4 receptor agonist properties, inhibiting dopamine-mediated suppression of gastrointestinal motility and central chemoreceptor trigger zone signaling. This dual antiemetic and prokinetic action enhances upper gastrointestinal smooth muscle contractions and accelerates gastric emptying, providing therapeutic efficacy in managing diabetic gastroparesis and post-operative nausea and vomiting.

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.