drugset / Trial / NCT00652808

Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Osteoarthritis of the Knee

NCT00652808

Phase 3 Completed 265 enrolled Pfizer
RandomizedParallel-groupTriple-blindTreatment

Summary

This study was performed to demonstrate that treatment with valdecoxib 10 mg daily (QD) was at least as effective as with naproxen 500 mg twice daily (BID), a standard non-steroidal anti-inflammatory drug (NSAID), when taken for 6 weeks in Korean subjects with symptomatic osteoarthritis (OA) of the knee. Secondary objectives were to assess the overall safety and tolerability of valdecoxib 10 mg QD taken for 6 weeks in Korean subjects with symptomatic OA of the knee.

Timeline

Start
2004-05
Primary completion
Completion
2004-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Naproxen Small molecule 500 mg Oral
Comparator valdecoxib Small molecule 10 mg Oral

Indications