Tenoxicam Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Several clinical trials have evaluated tenoxicam for pain management indications, focusing primarily on acute postoperative pain and obstetrical analgesia. Sponsored by academic and medical institutions including TC Erciyes University and Ain Shams Maternity Hospital, these studies encompass Phase 2 trials as well as those with a Not Applicable phase designation. Recruitment statuses across these initiatives include completed studies in post-surgical pain and trials with an unknown status addressing labor pain.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05508451	Completed	Postoperative Pain Acute	TC Erciyes University	2018-04-01	Not Applicable
NCT02549118	Unknown status	Analgesia\|Obstetrical	Ain Shams Maternity Hospital	2015-09	Phase 2
NCT02557087	Unknown status	Analgesia Obstetrical	Ain Shams Maternity Hospital	2015-09	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a non-steroidal anti-inflammatory agent, tenoxicam acts as a scavenger of hydroxyl radicals with an IC50 of 56.7 μM, neutralizing reactive oxygen species to prevent oxidative damage and suppress downstream pro-inflammatory signaling. This inhibition of oxidative stress and local inflammatory cascades mitigates nociceptive signaling, providing clinical utility in the management of acute postoperative pain and obstetrical analgesia.

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>).