Safety and Efficacy of Celecoxib Versus Naproxen in the 6-Month Treatment of Knee Osteoarthritis

NCT00643799

Last updated date
Study Location
Pfizer Investigational Site
Montgomery, Alabama, 36106, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Knee Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Osteoarthritis of the knee as defined by the American College of Rheumatology criteria in a flare state at baseline visit

- Functional Capacity Classification of I-III

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Inflammatory arthritis or gout/pseudo-gout with an acute flare within the past 2 years
(subjects with fibrositis or fibromyalgia will not be excluded)


- Received acetaminophen within 24 hours of the baseline visit


- Acute joint trauma at index joint within the past 3 months with active symptoms


- History of gastrointestinal (GI) perforation, obstruction, or bleeding


- Diagnosed or treated for GI ulcer within 60 days prior to first dose of study
medication


- Received corticosteroids or hyaluronic acid within certain timeframe before study

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  1. Montgomery, Alabama
  2. Phoenix, Arizona
  3. Tempe, Arizona
  4. Buena Park, California
  5. Paramount, California
  6. Rancho Mirage, California
  7. San Diego, California
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  9. Denver, Colorado
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  22. Wichita, Kansas
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  28. Greenbelt, Maryland
  29. Hagerstown, Maryland
  30. Wheaton, Maryland
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  32. Lansing, Michigan
  33. Flowood, Mississippi
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  35. Lincoln, Nebraska
  36. Lincoln, Nebraska
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  39. Columbus, Ohio
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  44. Duncansville, Pennsylvania
  45. Media, Pennsylvania
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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Celecoxib Versus Naproxen in the 6-Month Treatment of Knee Osteoarthritis
Official Title  ICMJE A Randomized, Multicenter, Double-Blind, Double-Dummy Study Comparing the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Naproxen 500 mg Twice Daily in the 6-Month Treatment of Subjects With Osteoarthritis of the Knee
Brief Summary To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • Drug: Celecoxib
    200 mg oral capsule once daily for 6 months
  • Drug: Naproxen
    500 mg oral capsule twice daily for 6 months
  • Drug: Placebo
    Matched oral placebo for 6 months
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Celecoxib
  • Active Comparator: B
    Intervention: Drug: Naproxen
  • Placebo Comparator: C
    Intervention: Drug: Placebo
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: March 18, 2008)
586
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2005
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Osteoarthritis of the knee as defined by the American College of Rheumatology criteria in a flare state at baseline visit
  • Functional Capacity Classification of I-III

Exclusion Criteria:

  • Inflammatory arthritis or gout/pseudo-gout with an acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
  • Received acetaminophen within 24 hours of the baseline visit
  • Acute joint trauma at index joint within the past 3 months with active symptoms
  • History of gastrointestinal (GI) perforation, obstruction, or bleeding
  • Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication
  • Received corticosteroids or hyaluronic acid within certain timeframe before study
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years and older   (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 NCT00643799
Other Study ID Numbers  ICMJE A3191152
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2008

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