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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis
• Knee

Interventions

Type	Name	Description
DRUG	valdecoxib	valdecoxib 10 mg tablet by mouth once daily for 6 weeks
DRUG	naproxen	naproxen 500 mg capsule by mouth twice daily for 6 weeks

Timeline

• Start date: 2004-05-01
• Completion: 2004-09-01
• First posted: 2008-04-04
• Last updated: 2008-04-10

Locations

8 sites across 1 country: South Korea