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Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (United States)

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ClinicalTrials.gov Identifier: NCT00620867
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE February 12, 2008
First Posted Date  ICMJE February 22, 2008
Last Update Posted Date February 21, 2021
Study Start Date  ICMJE October 2002
Actual Primary Completion Date March 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
Change from baseline in patient's assessment of arthritis pain according to visual analogue scale (VAS) [ Time Frame: Week 6 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2008)
  • Vital signs [ Time Frame: Weeks 2 and 6 ]
  • Physical examination [ Time Frame: Week 6 ]
  • Laboratory test results [ Time Frame: Week 6 ]
  • Adverse events [ Time Frame: Weeks 2 and 6 ]
  • Change from baseline in patient's and physician's global assessment of pain [ Time Frame: Weeks 2 and 6 ]
  • Pain Satisfaction Scale [ Time Frame: Days 1-7 ]
  • Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: Week 6 ]
  • Patient Health Questionnaire (PHQ-9) [ Time Frame: Week 6 ]
  • Change from baseline in patient's assessment of arthritis pain according to VAS [ Time Frame: Week 2 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
  • Vital signs [ Time Frame: Weeks 2 and 6 ]
  • Physical examination [ Time Frame: Week 6 ]
  • Laboratory test results [ Time Frame: Week 6 ]
  • Adverse events [ Time Frame: Weeks 2 and 6 ]
  • Change from baseline in patient's and physician's global assessment of pain [ Time Frame: Weeks 2 and 6 ]
  • Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: Week 6 ]
  • Pain Satisfaction Scale [ Time Frame: Days 1-7 ]
  • Patient Health Questionnaire (PHQ-9) [ Time Frame: Week 6 ]
  • Change from baseline in patient's assessment of arthritis pain according to VAS [ Time Frame: Week 2 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (United States)
Official Title  ICMJE A Study of the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Three Times Daily Ibuprofen vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee
Brief Summary To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.
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: Ibuprofen
    800 mg oral tablet three time daily with meals for 6 weeks
  • Drug: celecoxib
    200 mg oral capsule once daily with morning meal for 6 weeks
  • Other: placebo
    matched placebo orally for 6 weeks
Study Arms  ICMJE
  • Experimental: Ibuprofen
    Intervention: Drug: Ibuprofen
  • Experimental: Celecoxib
    Intervention: Drug: celecoxib
  • Placebo Comparator: placebo
    Intervention: Other: 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: February 12, 2008)
393
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2003
Actual Primary Completion Date March 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged >= 40 years old
  • Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit
  • Functional capacity class of I-III

Exclusion Criteria:

  • Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
  • Acute joint trauma at index joint within the past 3 months with active symptoms
  • Score of >=20 on PHQ-9 or score of >=1 on PHQ-9 item i
  • Use of mobility assisting device for <6 weeks or use of walker
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 NCT00620867
Other Study ID Numbers  ICMJE A3191063
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2021

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