Piroxicam Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

Several completed clinical trials have evaluated piroxicam across gynecological indications, specifically primary dysmenorrhea and postcoital contraception. Spanning Phase 2 and Phase 4 development, these studies encompass both academic and industry sponsors, including a Pamukkale University trial assessing analgesic efficacy and a Bayer trial investigating contraceptive applications. Together, these findings demonstrate the broad clinical utility of piroxicam in gynecological and pain management contexts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02253446	Completed	Primary Dysmenorrhea	Pamukkale University	2013-05	Phase 4
NCT01320709	Completed	Contraception Postcoital	Bayer	2011-03	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Piroxicam non-selectively binds to and inhibits cyclooxygenase enzymes, thereby blocking the downstream conversion of arachidonic acid into pro-inflammatory prostaglandins. This enzymatic blockade suppresses local inflammatory responses and nociceptive signaling, providing the therapeutic rationale for relieving pain in primary dysmenorrhea and supporting clinical evaluation in postcoital contraception.

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>).