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Clinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT01102660
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : August 22, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 12, 2010
First Posted Date  ICMJE April 13, 2010
Last Update Posted Date August 22, 2014
Study Start Date  ICMJE May 2010
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2010)
Western Ontario & McMaster Osteoarthritis Index Pain Score [ Time Frame: 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2010)
  • Western Ontario & McMaster Osteoarthritis Index Stiffness Score [ Time Frame: 2 weeks ]
  • Western Ontario & McMaster Osteoarthritis Index Physical Function Score [ Time Frame: 2 weeks ]
  • Western Ontario & McMaster Osteoarthritis Index Total Score [ Time Frame: 2 weeks ]
  • Daily Pain Rating Scale [ Time Frame: 2 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee
Official Title  ICMJE A Randomized, Double-Blind, Double-Dummy, Placebo And Active Controlled Two Period Four Treatment Cross-Over Clinical Trial To Examine The Pain Relief Of PH-797804 Alone Or With Naproxen In Subjects With Flare-Enriched Osteoarthritis Of The Knee
Brief Summary PH-797804 is a potent inhibitor of inflammatory mediators that have a potential role in pain signalling following nerve injury and inflammation. Blocking such mediators may potentially have a therapeutic benefit by reducing pain.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Drug: PH-797804
    Tablet, 6 mg once daily for 2 weeks
  • Drug: Placebo
    Tablet, 0 mg once daily for 2 weeks
  • Drug: Naproxen
    Tablet, 500 mg twice daily for 2 weeks
  • Drug: Naproxen + PH-797804
    Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks
Study Arms  ICMJE
  • Treatment Sequence 1
    Interventions:
    • Drug: PH-797804
    • Drug: Placebo
  • Treatment Sequence 2
    Interventions:
    • Drug: Placebo
    • Drug: PH-797804
  • Treatment Sequence 3
    Interventions:
    • Drug: Naproxen
    • Drug: Naproxen + PH-797804
  • Treatment Sequence 4
    Interventions:
    • Drug: Naproxen + PH-797804
    • Drug: Naproxen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2014)
172
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2010)
190
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects between, and including, the ages of 18 and 75 years. Females must be of non-childbearing potential.
  • Diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria with X-ray confirmation (a Kellgren-Lawrence X-ray grade of ≥2.

Exclusion Criteria:

  • History of diseases other than osteoarthritis that may involve the index knee.
  • Other severe pain that impairs the assessment of osteoarthritis of pain.
  • Electrocardiogram abnormalities.
  • History of gastrointestinal disorders.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01102660
Other Study ID Numbers  ICMJE A6631026
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2014

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