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PF-04136309 · 2 trials · 2 indications
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.
AUC(0-inf)=Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (o-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
| Arm | Type | Description |
|---|---|---|
| PF-04136309 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Experimental 1 | EXPERIMENTAL | All subjects will receive 2 treatments in one of the indicated sequence orders: A - B B - A |
| 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...
PF-04136309 is an investigational small molecule being studied for osteoarthritis of the knee and in healthy volunteers. It was evaluated in a Phase 2 study for osteoarthritic knee pain and in a Phase 1 food effect study in healthy subjects. It is not approved and remains in clinical development.
PF-04136309 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company sponsored clinical trials of the drug in the United States, South Korea, and Belgium.
PF-04136309 is in clinical development, with completed Phase 1 and Phase 2 trials. The most advanced study was a Phase 2 trial in osteoarthritis of the knee, which has been completed. The drug is investigational and not FDA approved.
PF-04136309 has been studied in two completed trials. NCT00689273 was a randomized, double-blind, placebo-controlled Phase 2 study in subjects with osteoarthritic pain of the knee, enrolling 159 participants in the United States and South Korea. NCT02598206 was a Phase 1 food effect study in 18 healthy volunteers in Belgium.
No alternative names for PF-04136309 have been disclosed in the clinical trial records. The drug is identified solely by its compound number PF-04136309 in the studies listed.