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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00630929
First received: February 28, 2008
Last updated: September 10, 2008
Last verified: September 2008

February 28, 2008
September 10, 2008
January 2003
Not Provided
Change from baseline in patient's assessment of arthritis pain according to visual analogue scale [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00630929 on ClinicalTrials.gov Archive Site
  • Change from baseline in American Pain Society Modified Brief Pain Inventory Short Form pain scores [ Time Frame: Days 1-7 ] [ Designated as safety issue: No ]
  • Change from baseline in patient's assessment of arthritis pain according to visual analogue scale [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Change from baseline in patient and physician global assessments of arthritis [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: No ]
  • Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • The Pain Satisfaction Scale [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • The Patient Health Questionnaire (PHQ-9) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Measurement of upper gastrointestinal tolerability [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: Yes ]
  • Laboratory test results [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: Yes ]
  • Physical examination [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (Europe)
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

To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Osteoarthritis, Knee
  • Drug: Ibuprofen
    800 mg oral tablet 3 times daily with meals for 6 weeks
  • Drug: Placebo
    Matched placebo orally for 6 weeks
  • Drug: Celecoxib
    200 mg oral capsule once daily with morning meal for 6 weeks
  • Active Comparator: A
    Intervention: Drug: Ibuprofen
  • Placebo Comparator: C
    Intervention: Drug: Placebo
  • Experimental: B
    Intervention: Drug: Celecoxib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
388
February 2004
Not Provided

Inclusion Criteria:

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:

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Spain,   United Kingdom
 
NCT00630929
A3191062
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2008

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