A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee

• Status: Terminated
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

PF-04191834 works in animal models by inhibiting one of the enzymes, 5-lipoxygenasein which is involved in the pathway that causes inflammation and pain. The purpose of this study is to test how effective, safe and tolerated PF-04191834 is in patients with osteoarthritis of the knee by itself or with naproxen, particularly to test if patients have less pain.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Naproxen

Criteria

Inclusion Criteria:

• Subjects must have a diagnosis of osteoarthritis based on the American College of Rheumatology criteria confirmed by an X-ray

• Subjects must be willing and able to stop all current pain therapy for the duration of the study

• Subjects must be willing and able to complete a daily diary

Exclusion Criteria:

• BMI of >39 kg/m2

• Known allergy or hypersensitivity to naproxen

• Any condition or medical history that might interfere with the subject's ability to complete the study visits and assessments