A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee
- Registration Number
- NCT00981357
- Lead Sponsor
- Pfizer
- Brief Summary
Inactivation of the FAAH (Fatty Acid Amide Hydrolase) enzyme has been shown to relieve pain and inflammation in animal studies. PF-04457845 has been shown to inactivate the FAAH enzyme in animals and healthy human volunteers. The purpose of this study is to evaluate whether PF-04457845 can inactivate the FAAH enzyme in patients experiencing pain due to OA and whether this results in these patients experiencing less pain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- Subjects must have a diagnosis of Osteoarthritis (OA) of the knee confirmed by X-ray
- Subjects must be willing and able to stop all current pain therapy for the duration of study. (Limited and specific pain therapy will be available throughout the study)
- Subjects can be male or female between the ages of 18 and 75 years inclusive, but female subjects must not be able become pregnant
- Subjects must not have any condition or medical history that might interfere with their ability to complete the study assessments
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo followed by Naproxen Naproxen - Naproxen followed by placebo Naproxen - PF-04457845 followed by placebo PF-04457845 - Placebo followed by PF-04457845 PF-04457845 -
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of PF-04457845 (administered QD) versus placebo in relieving pain as measured by the WOMAC Pain sub-score in patients with osteoarthritis of the knee 8 weeks To evaluate the safety and tolerability of PF-04457845 in patients with osteoarthritis. 10 weeks
- Secondary Outcome Measures
Name Time Method Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Stiffness domain score (Likert scale for 2 items, overall score ranges from 0-8) in patients with osteoarthritis of the knee. 8 weeks Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Physical Function domain score (Likert scale for 17 items, overall score ranges from 0-68) in patients with osteoarthritis of the knee. 8 weeks Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Total Score in patients with osteoarthritis of the knee. 8 weeks Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Importance weighted Total WOMAC score in patients with osteoarthritis of the knee. 8 weeks Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Daily pain diary over weeks 1 and 2 of each treatment period using an 11-point Numeric Rating Scale (NRS) in patients with osteoarthritis of the knee. 8 weeks Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Subjects' use of rescue medication on either treatment. 8 weeks Summary of plasma concentrations of PF-04457845. 8 weeks Residual FAAH activity in leukocytes for subjects recruited prior to the interim analysis. 8 weeks Plasma fatty acid amide levels (OEA, PEA, LEA and AEA) for subjects recruited prior to the interim analysis. 8 weeks
Trial Locations
- Locations (6)
Arthritis & Rheumatic Care Center
🇺🇸Miami, Florida, United States
CEDRA Clinical Research, LLC
🇺🇸San Antonio, Texas, United States
Centrum for klinisk provning
🇸🇪Goteborg, Sweden
Diex Research Inc.
🇨🇦Sherbrooke, Quebec, Canada
Miami Research Associates
🇺🇸Miami, Florida, United States
Vince and Associates Clinical Research
🇺🇸Overland Park, Kansas, United States