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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-014734-16 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04457845 followed by placebo | Experimental |
| |
| Placebo followed by PF-04457845 | Experimental |
| |
| Naproxen followed by placebo | Active Comparator |
| |
| Placebo followed by Naproxen | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04457845 | Drug | PF-04457845 4 mg tablet once daily / matched placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthritis & Rheumatic Care Center | Miami | Florida | 33143 | United States | ||
| Miami Research Associates |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| PF-04457845 |
| Drug |
PF-04457845 4 mg tablet once daily / matched placebo |
|
| Naproxen | Drug | Naproxen 500 mg tablet twice daily / matched placebo |
|
| Naproxen | Drug | Naproxen 500 mg tablet twice daily / matched placebo |
|
| 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 |
| Miami |
| Florida |
| 33143 |
| United States |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66211 | United States |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
| CEDRA Clinical Research, LLC | San Antonio | Texas | 78217 | United States |
| Diex Research Inc. | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| Centrum for klinisk provning | Gothenburg | 405 30 | Sweden |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C560620 | N-pyridazin-3-yl-4-(3-((5-(trifluoromethyl)pyridin-2-yl)oxy)benzylidene)piperidine-1-carboxamide |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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