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A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee

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ClinicalTrials.gov Identifier: NCT00981357
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: PF-04457845 Drug: Naproxen Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Naproxen

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. To evaluate the safety and tolerability of PF-04457845 in patients with osteoarthritis. [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Subjects' use of rescue medication on either treatment. [ Time Frame: 8 weeks ]
  7. Summary of plasma concentrations of PF-04457845. [ Time Frame: 8 weeks ]
  8. Residual FAAH activity in leukocytes for subjects recruited prior to the interim analysis. [ Time Frame: 8 weeks ]
  9. Plasma fatty acid amide levels (OEA, PEA, LEA and AEA) for subjects recruited prior to the interim analysis. [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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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
Keywords provided by Pfizer:
Cross-over evaluate the efficacy of PF-04457845 in relieving pain due to osteoarthritis OA knee osteoarthritis of knee pain due to osteoarthritis
Additional relevant MeSH terms:
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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