Indometacin Sodium Clinical Trials

Size	Price	Qty
25mg	USD 97
1g	USD 970

Clinical Trials

Multiple clinical trials evaluate indomethacin and its formulations across indications including post-endoscopic retrograde cholangiopancreatography pancreatitis, patent ductus arteriosus in premature neonates, migraine headaches, and healthy volunteer responses. Spanning Early Phase 1, Phase 2, and non-interventional or non-applicable designs, these studies demonstrate recruitment statuses ranging from completed to withdrawn and unknown. Sponsorship is distributed among academic medical centers, university health networks, professional research societies, and industry entities such as Janssen Research & Development LLC.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06031363	Completed	Pancreatitis\|Cholangiopancreatography Endoscopic Retrograde\|Indomethacin	The First Affiliated Hospital of Soochow University	2022-11-01	Not Applicable
NCT04821323	Completed	Healthy	Janssen Research & Development LLC	2021-03-10	Early Phase 1
NCT04025177	Withdrawn	Patent Ductus Arteriosus After Premature Birth	University of Manitoba\|St. Boniface Hospital\|Health Sciences Centre Winnipeg Manitoba\|University at Buffalo	2020-01	Phase 2
NCT03967483	Unknown status	Headache Migraine	Anne Ducros\|French Society for the Study of Migraine Headache	2019-06-01	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Indometacin sodium reversibly and competitively binds to cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), thereby inhibiting the enzymatic conversion of arachidonic acid into pro-inflammatory prostaglandins and thromboxanes. By suppressing local prostaglandin biosynthesis, this compound mitigates vascular permeability, hyperalgesia, and acute inflammatory cascades, providing therapeutic relevance in clinical conditions such as post-procedural pancreatitis, inflammatory headaches, and patent ductus arteriosus.

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>).