Conditions: Osteoarthritis, Knee
Keywords: Cross-over safety efficacy tolerability osteoarthritis knee pain
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 190
Healthy volunteers: no

Brief 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.

Detailed description:
This study has been terminated in response to a reported serious adverse event (SAE). The sponsor's assessment of the limited data available at the time of the initial SAE report was that the SAE may alter the potential benefit - risk profile of the study medication.

Arms:
arm 1: PF-04191834 600 mg BID dose followed by matched placebo plus naproxen placebo. arm 2: Placebo followed by 600 mg BID dose of PF-04191834 plus naproxen placebo. arm 3: PF-04191834 600 mg BID + Naproxen 500 mg BID followed by Naproxen 500 mg BID plus PF-04191834 placebo arm 4: Naproxen 500 mg BID followed by PF-04191834 600 mg BID + Naproxen 500 mg BID

Interventions: intervention 1: PF-04191834 intervention 2: PF-04191834 placebo intervention 3: Naproxen placebo intervention 4: PF-04191834 placebo intervention 5: PF-04191834 intervention 6: Naproxen placebo intervention 7: PF-04191834 intervention 8: Naproxen intervention 9: PF-04191834 placebo intervention 10: Naproxen intervention 11: PF-04191834 placebo intervention 12: PF-04191834
Intervention descriptions: intervention 1: 100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks intervention 2: Matching PF-04191834 placebo tablets to be administered BID for two weeks intervention 3: Matching naproxen placebo tablets to be administered BID for 4 weeks intervention 4: Matching PF-04191834 placebo tablets to be administered BID for two weeks intervention 5: 100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks intervention 6: Matching naproxen placebo tablets to be administered BID for 4 weeks intervention 7: 100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks intervention 8: Naproxen 500 mg tablet administered BID for a total of four weeks intervention 9: Matching PF-04191834 placebo tablets to be administered BID for two weeks intervention 10: Naproxen 500 mg tablet administered BID for a total of four weeks intervention 11: Matching PF-04191834 placebo tablets to be administered BID for two weeks intervention 12: 100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks

Protocol document: