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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00981357 |
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Date of registration:
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21/09/2009 |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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76 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00981357 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Canada
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South Africa
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Sweden
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Osteoarthritis, Knee
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Intervention(s)
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Drug: Naproxen
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Drug: PF-04457845
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Primary Outcome(s)
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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]
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To evaluate the safety and tolerability of PF-04457845 in patients with osteoarthritis.
[Time Frame: 10 weeks]
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Secondary Outcome(s)
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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]
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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]
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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]
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Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Subjects' use of rescue medication on either treatment.
[Time Frame: 8 weeks]
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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]
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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]
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Plasma fatty acid amide levels (OEA, PEA, LEA and AEA) for subjects recruited prior to the interim analysis.
[Time Frame: 8 weeks]
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Residual FAAH activity in leukocytes for subjects recruited prior to the interim analysis.
[Time Frame: 8 weeks]
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Summary of plasma concentrations of PF-04457845.
[Time Frame: 8 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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