Conditions: Osteoarthritis, Knee
Keywords: PF-04136309 CCR2 osteoarthritic pain knee phase 2 placebo multicenter double-blind placebo-controlled
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 159
Healthy volunteers: no

Brief summary:
To evaluate the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics in patients with osteoarthritic pain of the knee. The most painful knee joint will be identified as the index joint at screening, and this joint will be used for all pain assessments throughout the study.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: PF-04136309 intervention 2: Placebo
Intervention descriptions: intervention 1: 125 mg capsules. Dose will be 4 capsules BID for 2 weeks for a total of 500 mg for each dosing interval. intervention 2: Placebo will be matched to PF-04136309. Dose, frequency, and duration same as PF-04136309.

Protocol document: