Rofecoxib Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Multiple clinical trials sponsored by industrial entities such as AstraZeneca and academic centers like the M.D. Anderson Cancer Center have evaluated rofecoxib across gastrointestinal and oncological indications. These Phase 1 and Phase 4 studies include a completed trial assessing rofecoxib's effects on prostaglandin production in Barrett's esophagus, alongside a terminated investigation combining rofecoxib with radiation therapy for glioma and brain neoplasms.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00637988	Completed	Barrett''s Esophagus	AstraZeneca	2002-04	Phase 4
NCT00038389	Terminated	Glioma\|Brain Neoplasms	M.D. Anderson Cancer Center	2001-10	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rofecoxib selectively binds to and inhibits cyclooxygenase-2 (COX-2) with an IC50 of 18 nM, thereby blocking the downstream conversion of arachidonic acid into pro-inflammatory prostaglandin E2. This inhibition suppresses prostaglandin-mediated signaling, cellular proliferation, and inflammatory pathways, directly supporting its investigation in therapeutic settings such as Barrett's esophagus and glioma.

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>).