Dimenhydrinate Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Multiple clinical trials have evaluated dimenhydrinate for the management of motion sickness, nausea, vomiting, and vertigo. Consisting entirely of late-stage Phase 3 and Phase 4 research, these trials have reached completed recruitment status and evaluated interventions such as a nasal gel formulation and comparisons with metoclopramide. Study sponsors include industry collaborators Repurposed Therapeutics Inc. and Defender Pharmaceuticals Inc., alongside academic entities such as Pamukkale University.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04947423	Completed	Motion Sickness	Repurposed Therapeutics Inc.\|Defender Pharmaceuticals Inc.	2021-06-14	Phase 3
NCT02253524	Completed	Nausea\|Vomiting\|Vertigo	Pamukkale University	2012-11	Phase 4

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dimenhydrinate competitively binds to central histamine H1 receptors, thereby blocking downstream histaminergic signal transduction within the vestibular system and the chemoreceptor trigger zone. This receptor blockade suppresses central neuronal excitability and emetic pathway activation, directly mitigating clinical manifestations of motion sickness, nausea, vomiting, and vertigo.

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>).