Otilonium Bromide Clinical Trials

Size	Price	Qty
10mg	USD 147
100mg	USD 497

Clinical Trials

Multiple completed Phase IV clinical trials have evaluated the efficacy of otilonium bromide in treating gastrointestinal conditions. These hospital- and university-sponsored studies assessed its utility as a spasmolytic agent during upper gastrointestinal endoscopy and compared pharmacotherapy to dietary interventions for managing irritable bowel syndrome.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04270487	COMPLETED	Irritable Bowel Syndrome	Universitaire Ziekenhuizen KU Leuven	2018-07-26	PHASE4
NCT02576340	COMPLETED	Gastroscopy	Konya Meram State Hospital	2013-01	PHASE4

(data from https://clinicaltrials.gov, updated on 2020-11-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Otilonium bromide acts as an antimuscarinic agent that binds to muscarinic acetylcholine receptors, thereby blocking intracellular cholinergic signaling cascades and preventing calcium influx in smooth muscle cells. This cellular inhibition suppresses involuntary gastrointestinal smooth muscle contractions, delivering crucial spasmolytic activity required for managing irritable bowel syndrome and facilitating upper gastrointestinal gastroscopy procedures.

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>).