Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00689273 | Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain Of The Knee | PHASE2 | COMPLETED | 159 | — | — | Aug 5, 2008 | Nov 27, 2008 | Jul 13, 2021 | 22 | United States, South Korea |
WOMAC: self-administered, disease-specific 24 item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness, and physical function in participants with osteoarthritis (OA) of the hip and/or knee. It consists of 3 domains: pain, stiffness and physical function. WOMAC pain domain consists of 5 questions scored on 5 point Likert scale (0=minimum pain to 4=maximum pain) where higher score indicates higher pain. It assesses amount of pain experienced due to OA in the study joint in past 48 hours. Total possible pain domain score calculated by addition of scores of each 5 questions ranged from: 0 (minimum) - 20 (maximum), higher scores indicate higher pain.
| Arm | Type | Description |
|---|---|---|
| PF-04136309 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PF-04136309 | DRUG | 125 mg capsules. Dose will be 4 capsules BID for 2 weeks for a total of 500 mg for each dosing interval. |
| Placebo | DRUG | Placebo will be matched to PF-04136309. Dose, frequency, and duration same as PF-04136309. |
Inclusion Criteria: * Male or female of any race, between the ages of 18 and 75 years inclusive * Female subjects must be of non-childbearing potential and have a negative pregnancy test at Screening. * Osteoarthritis of the knee of at least 6 months duration and meeting the American College of Rhe...