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Safety and Efficacy of Celecoxib Versus Placebo in the Treatment of Knee Osteoarthritis in Patients Who Were Unresponsive to Naproxen and Ibuprofen

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00638807
First received: March 12, 2008
Last updated: March 12, 2009
Last verified: March 2009

March 12, 2008
March 12, 2009
December 2003
Not Provided
Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00638807 on ClinicalTrials.gov Archive Site
  • Patient's Assessment of Arthritis Pain, according to VAS [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • The Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Patient's and Physician's Global Assessment of Arthritis [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: No ]
  • The Medical Outcomes Study Sleep Scale [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Weeks 0-6 ] [ Designated as safety issue: Yes ]
  • Laboratory tests [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
  • Physical examination [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
  • Serious adverse events [ Time Frame: Up to 30 days after last dose ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Celecoxib Versus Placebo in the Treatment of Knee Osteoarthritis in Patients Who Were Unresponsive to Naproxen and Ibuprofen
A Double-Blind, Placebo Controlled Study of the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee Non-Responsive to Naproxen and Ibuprofen

To compare the efficacy and safety of celecoxib versus placebo for the treatment of knee osteoarthritis (OA) in patients who were unresponsive to prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen

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: Celecoxib
    200 mg oral capsule once daily with morning meal for 6 weeks
  • Other: Placebo
    Matched oral placebo for 6 weeks
  • Experimental: A
    Intervention: Drug: Celecoxib
  • Placebo Comparator: B
    Intervention: Other: Placebo
Not Provided

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

Inclusion Criteria:

Inclusion criteria:

  • Diagnosed, active, and symptomatic OA of the knee in a flare state with a functional capacity class of I-III at baseline visit
  • Failed adequate trials of both naproxen and ibuprofen (prescription strength) within the past 5 years due to lack of efficacy, tolerability, or both; duration of prescription strength ibuprofen and naproxen must have been a minimum of 2 weeks for each drug at the respective recommended doses if failure was due to lack of efficacy, and for any duration if failure was due to lack of tolerability

Exclusion Criteria:

Exclusion criteria:

  • Inflammatory arthritis or gout/pseudo-gout with 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
  • Use of a mobility assisting device for less than six weeks prior to study screening or use of a walker
  • 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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00638807
A3191082
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2009

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