drugset / Trial / NCT00542555

Analgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee

NCT00542555 ↗

Phase 3 Completed 918 enrolled NicOx
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To study the efficacy and safety of naproxcinod vs. placebo and naproxen in the treatment of signs and symptoms of Osteoarthritis.

Timeline

Start
2005-12
Primary completion
—
Completion
2007-09

Outcome

Met primary endpoint

paper Both doses of naproxcinod were statistically and clinically superior to placebo in relieving signs and symptoms of OA of the knee after 13 weeks of treatment, as demonstrated by all three co-primary endpoints (P< or =0.0003). PMID 20202489 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Naproxen Small molecule 500 mg —
Subject naproxcinod Other / unclassified 375 mg —
Subject naproxcinod Other / unclassified 750 mg —

Indications