Naproxen Sodium Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Several clinical trials are evaluating naproxen sodium across diverse medical conditions, including dysmenorrhea, orthodontic pain, soft tissue injury, and Lynch syndrome-associated colorectal cancer. Spanning Phase 1, Phase 2, and Phase 4 development with recruitment statuses reported as recruiting or completed, these studies are sponsored by major academic and government entities—such as the National Institutes of Health, M.D. Anderson Cancer Center, McLean Hospital, and the Department of Defense—alongside commercial pharmaceutical companies including Bayer and Johnson & Johnson.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05900336	Recruiting	Dysmenorrhea\|Menstrual Pain\|Non-steroidal Anti-inflammatory Drug	Mclean Hospital\|United States Department of Defense\|NorthShore University HealthSystem	2024-03-25	Phase 4
NCT05844995	Completed	Orthodontic Pain	Johnson & Johnson Consumer Inc. (J&JCI)\|Johnson & Johnson Consumer and Personal Products Worldwide	2023-09-13	Phase 1
NCT05411718	Recruiting	T Cells\|Colorectal Cancer\|Lynch Syndrome	M.D. Anderson Cancer Center\|National Institutes of Health (NIH)\|National Cancer Institute (NCI)	2023-03-21	Phase 2
NCT05026320	Completed	Soft Tissue Injury	Bayer\|Deutsche Sporthochschule Köln	2021-08-08	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Naproxen Sodium acts as a non-selective inhibitor of cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), blocking the enzymatic conversion of arachidonic acid into pro-inflammatory prostaglandins. This inhibition attenuates vascular permeability, hyperalgesia, and downstream inflammatory signaling, thereby exerting therapeutic analgesic and anti-inflammatory effects relevant to clinical indications including dysmenorrhea, soft tissue injury, orthodontic pain, and colorectal cancer interception in Lynch syndrome.

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>).