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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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00981357
First received: September 21, 2009
Last updated: June 2, 2011
Last verified: June 2011
History of Changes

September 21, 2009
June 2, 2011
November 2009
May 2010   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of PF-04457845 in patients with osteoarthritis. [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00981357 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Subjects' use of rescue medication on either treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Summary of plasma concentrations of PF-04457845. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Residual FAAH activity in leukocytes for subjects recruited prior to the interim analysis. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Plasma fatty acid amide levels (OEA, PEA, LEA and AEA) for subjects recruited prior to the interim analysis. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis, Knee
  • Drug: PF-04457845
    PF-04457845 4 mg tablet once daily / matched placebo
  • Drug: Naproxen
    Naproxen 500 mg tablet twice daily / matched placebo
  • Experimental: PF-04457845 followed by placebo
    Intervention: Drug: PF-04457845
  • Experimental: Placebo followed by PF-04457845
    Intervention: Drug: PF-04457845
  • Active Comparator: Naproxen followed by placebo
    Intervention: Drug: Naproxen
  • Active Comparator: Placebo followed by Naproxen
    Intervention: Drug: Naproxen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Sweden
 
NCT00981357
B0541004
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP