A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00981357 |
Recruitment Status :
Completed
First Posted : September 22, 2009
Last Update Posted : September 19, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis, Knee | Drug: PF-04457845 Drug: Naproxen | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 76 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2a Randomized, Double-blinded, Double Dummy, Placebo And Active Controlled, Two-way Cross-over, Flare-enriched Multi-centre Clinical Trial To Examine The Pain Relief Produced By 2 Weeks Of Daily Oral Administration Of A Fatty Acid Amide Hydrolase (Faah) Inhibitor Pf-04457845 In Patients With Osteoarthritis Of The Knee. |
Actual Study Start Date : | November 2009 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | May 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: PF-04457845 followed by placebo |
Drug: PF-04457845
PF-04457845 4 mg tablet once daily / matched placebo |
Experimental: Placebo followed by PF-04457845 |
Drug: PF-04457845
PF-04457845 4 mg tablet once daily / matched placebo |
Active Comparator: Naproxen followed by placebo |
Drug: Naproxen
Naproxen 500 mg tablet twice daily / matched placebo |
Active Comparator: Placebo followed by Naproxen |
Drug: Naproxen
Naproxen 500 mg tablet twice daily / matched placebo |
- 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 [ Time Frame: 8 weeks ]
- To evaluate the safety and tolerability of PF-04457845 in patients with osteoarthritis. [ Time Frame: 10 weeks ]
- 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. [ Time Frame: 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. [ Time Frame: 8 weeks ]
- Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Total Score in patients with osteoarthritis of the knee. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 8 weeks ]
- Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Subjects' use of rescue medication on either treatment. [ Time Frame: 8 weeks ]
- Summary of plasma concentrations of PF-04457845. [ Time Frame: 8 weeks ]
- Residual FAAH activity in leukocytes for subjects recruited prior to the interim analysis. [ Time Frame: 8 weeks ]
- Plasma fatty acid amide levels (OEA, PEA, LEA and AEA) for subjects recruited prior to the interim analysis. [ Time Frame: 8 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Subjects must not have any condition or medical history that might interfere with their ability to complete the study assessments

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981357
United States, Florida | |
Arthritis & Rheumatic Care Center | |
Miami, Florida, United States, 33143 | |
Miami Research Associates | |
Miami, Florida, United States, 33143 | |
United States, Kansas | |
Vince and Associates Clinical Research | |
Overland Park, Kansas, United States, 66211 | |
Vince and Associates Clinical Research | |
Overland Park, Kansas, United States, 66212 | |
United States, Texas | |
CEDRA Clinical Research, LLC | |
San Antonio, Texas, United States, 78217 | |
Canada, Quebec | |
Diex Research Inc. | |
Sherbrooke, Quebec, Canada, J1H 1Z1 | |
Sweden | |
Centrum for klinisk provning | |
Goteborg, Sweden, 405 30 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00981357 |
Other Study ID Numbers: |
B0541004 2009-014734-16 ( EudraCT Number ) |
First Posted: | September 22, 2009 Key Record Dates |
Last Update Posted: | September 19, 2017 |
Last Verified: | September 2017 |
Cross-over evaluate the efficacy of PF-04457845 in relieving pain due to osteoarthritis OA knee osteoarthritis of knee pain due to osteoarthritis |
Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Naproxen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |