Clinical Trials

Multiple clinical trials across Phase 2, Phase 3, and Phase 4 have evaluated lumiracoxib for managing pain, osteoarthritis, rheumatoid arthritis, acute gouty arthritis, and arthralgia, alongside pharmacodynamic assessments in healthy volunteers and patients with controlled hypertension or chronic kidney failure. Sponsored primarily by pharmaceutical industry leaders such as Novartis and medical institutions like Hospital Central Sur de Pemex, the majority of these trials are completed, though a subset was terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01481610 TERMINATED
Kidney Failure, Chronic; Arthralgia
Hospital Central Sur de Pemex
 2012-01 PHASE2
NCT00154219 COMPLETED
Osteoarthritis, Hip
Novartis
 2004-11 PHASE3
NCT00267176 COMPLETED
Osteoarthritis; Controlled Hypertension
Novartis Pharmaceuticals
 2005-11 PHASE4
NCT00348491 COMPLETED
Pain
Novartis Pharmaceuticals
 2006-02 PHASE4
NCT00350155 Completed
Healthy Volunteers
Novartis
 2006-05 Phase 4
NCT00348491 Completed
Pain
Novartis Pharmaceuticals|Novartis
 2006-02 Phase 4
NCT00145301 COMPLETED
Osteoarthritis
Novartis
 2004-09 PHASE3
NCT00267176 Completed
Osteoarthritis|Controlled Hypertension
Novartis Pharmaceuticals|Novartis
 2005-11 Phase 4
NCT00170872 COMPLETED
Osteoarthritis; Rheumatoid Arthritis
Novartis
 2004-11 PHASE3
NCT00475800 COMPLETED
Osteoarthritis
Novartis
 2004-01 PHASE3
NCT00170872 Completed
Osteoarthritis|Rheumatoid Arthritis
Novartis
 2004-11 Phase 3
NCT00476034 COMPLETED
Osteoarthritis
Novartis
 2003-12 PHASE3
NCT00145301 Completed
Osteoarthritis
Novartis
 2004-09 Phase 3
NCT00366938 COMPLETED
Osteoarthritis, Knee
Novartis
 2003-09 PHASE3
NCT00367315 COMPLETED
Knee Osteoarthritis
Novartis
 2003-09 PHASE3
NCT00475800 Completed
Osteoarthritis
Novartis
 2004-01 Phase 3
NCT00637949 COMPLETED
Osteoarthritis
Novartis
 2000-12 PHASE3
NCT00267215 COMPLETED
Osteoarthritis
Novartis
 2000-11 PHASE3
NCT00350155 COMPLETED
Healthy Volunteers
Novartis
 2006-05 PHASE4
NCT00170898 COMPLETED
Musculoskeletal Pain
Novartis
 2004-11 PHASE4
NCT00170781 COMPLETED
Acute Gouty Arthritis
Novartis
 2005-06 PHASE4
NCT00419796 COMPLETED
Osteoarthritis With Controlled Hypertension
Novartis
 2006-11 PHASE4
NCT00333567 COMPLETED
Pain
Novartis
 2006-08 PHASE4

(data from https://clinicaltrials.gov, updated on 2013-02-13)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lumiracoxib is a highly selective cyclooxygenase-2 inhibitor (Ki = 0.06 μM) that preferentially targets COX-2 over COX-1 (Ki = 3 μM), thereby blocking the enzymatic conversion of arachidonic acid into pro-inflammatory prostaglandins. By suppressing downstream prostaglandin E2 synthesis, Lumiracoxib reduces localized inflammatory signaling and nociceptor sensitization, providing therapeutic alleviation of joint pain and tissue inflammation in clinical conditions such as osteoarthritis and rheumatoid arthritis.

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>).

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Note: Technical data last updated: Sep 1, 2026.