Safety and Efficacy of Celecoxib Versus Naproxen in the 6-Month Treatment of Knee Osteoarthritis
NCT00643799
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- 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
- 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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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | 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 |
| |||
PRS Account | Pfizer | |||
Verification Date | January 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |