drugset / Trial / NCT00650455

Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients

NCT00650455

Phase 4 Completed 489 enrolled Pfizer
Parallel-groupDouble-blindTreatment

Summary

The objectives of the study were to evaluate the efficacy, safety, and tolerability of valdecoxib 10 mg once daily (QD) or naproxen 500 mg twice daily (BID) versus placebo, and to assess the efficacy of valdecoxib 10 mg QD versus naproxen 500 mg BID, in treating the signs and symptoms of rheumatoid arthritis (RA) in a severe Rheumatoid Arthritis population.

Timeline

Start
2003-02
Primary completion
2005-01
Completion
2005-01

Drugs

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

Indications