Valdecoxib Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

A completed clinical trial evaluated valdecoxib for neurosurgery and perioperative pain management by assessing its central nervous system penetration and modulation of biochemical markers linked to pain and neuronal sensitization. Collaboratively sponsored by academic and industry partners—the University of Washington and Pfizer—this late-phase study investigated the drug's central analgesic mechanisms and surgical pain control.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00122096	Completed	Neurosurgery\|Pain	University of Washington\|Pfizer	2002-11	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Valdecoxib functions as a potent and selective inhibitor of cyclooxygenase-2 (COX-2) with an IC50 of 5 nM, selectively blocking the conversion of arachidonic acid into pro-inflammatory prostaglandins. By suppressing localized prostaglandin synthesis, it attenuates peripheral nociceptive signal transduction, offering therapeutic efficacy for pain management in neurosurgical contexts.

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>).