Metamizole sodium hydrate Clinical Trials

Size	Price	Qty
25mg	USD 99

Clinical Trials

Multiple clinical trials evaluate the therapeutic utility, pharmacokinetics, and drug interactions of metamizole across Phase 2, Phase 3, Phase 4, and unassigned study designs. Sponsored primarily by academic institutions and university medical centers, these investigations focus on conditions including pediatric post-surgical pain, ischemic stroke, internal medicine management in elderly patients, post-tonsillectomy recovery, knee arthroscopy, and myofascial pain syndromes. Recruitment statuses across these studies are predominantly completed, with select trials marked as unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02660177	Completed	Children\|Pain\|Surgery	University Children''s Hospital Basel	2016-04	Phase 2
NCT02148939	Completed	Ischemic Stroke	Heinrich-Heine University Duesseldorf	2014-05	--
NCT02712268	Completed	Elderly Internal Medicine Patients	University Hospital Basel Switzerland	2013-09	Not Applicable
NCT00410332	Unknown status	Post-Tonsillectomy	Shaare Zedek Medical Center	2011-03	Phase 3
NCT00799149	Completed	Knee Arthroscopy	Meir Medical Center	2006-06	Phase 4
NCT00635037	Completed	Myofascial Pain Syndromes	Federal University of São Paulo	2004-06	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Metamizole sodium hydrate acts as a potent inhibitor of cyclooxygenase enzymes, thereby suppressing the biosynthesis of pro-inflammatory prostaglandins from arachidonic acid to attenuate nociceptive signal transduction and central pyrexia. This inhibition of prostaglandin-driven inflammatory and nociceptive cascades provides the mechanistic basis for its analgesic, antipyretic, and spasmolytic effects in managing clinical conditions such as post-surgical pain, ischemic stroke, and myofascial pain syndromes.

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>).