A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee
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.
Timeline
- Start
- 2010-07
- Primary completion
- 2011-02
- Completion
- 2011-02
Outcome
Missed primary endpoint
Stopped: “See termination reason in detailed description.”
registry analysis (superiority or other test); PF-04191834 Followed by Placebo vs Placebo Followed by PF-04191834; p = 0.067; Mean Difference (Net) 0.56 (80% CI 0.08 to 1.04); ANCOVA NCT01147458 ↗
registry analysis (superiority or other test); PF-04191834 + Naproxen Followed by Naproxen vs Naproxen Followed by PF-04191834 + Naproxen; p = 0.701; Mean Difference (Net) -0.20 (80% CI -0.67 to 0.28); ANCOVA NCT01147458 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naproxen | Small molecule | 500 mg | Oral |
| Subject | PF-4191834 | Small molecule | 600 mg | Oral |