NCT00542555View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL

Enrollment

918

Participants

Timeline

Start Date

December 31, 2005

Study Completion Date

September 30, 2007

Conditions

Osteoarthritis

Interventions

DRUG

Placebo

At 13 weeks, the patients receiving placebo were re-randomized to receive either naproxcinod 375 mg bid or naproxcinod 750 mg bid in a 1:1 ratio in the 301E study.

DRUG

Naproxcinod 375 mg

DRUG

Naproxen

DRUG

Naproxcinod 750 mg