Status:
COMPLETED
A Double-Blind, Double Dummy, Randomized Comparison Study Of The Efficacy And Safety Of Valdecoxib 10mg Once Daily And Naproxen 500mg Twice Daily In Treating The Signs And Symptoms Of Osteoarthritis Of The Knee Or Hip In Taiwan
Lead Sponsor:
Pfizer
Conditions:
Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy, safety, and tolerability of valdecoxib by comparing valdecoxib 10 mg daily (QD) with naproxen 500 mg twice daily (BID) in treating the signs and symptoms of osteoarthritis (O...
Eligibility Criteria
Inclusion
- The diagnosis of hip OA, which was having hip pain and meeting criteria for at least 2 of the following: a. Westergren erythrocyte sedimentation rate of \< 20 mm/hr; b. radiographic femoral or acetabular osteophytes or c. radiographic joint space narrowing
- Knee OA diagnosis required diagnosing (by modified American College of Rheumatology criteria) OA of the knee with pain plus at least one of the following: a. Age\> 50 years old, b. Stiffness \< 30 minutes, c. crepitus on active motion and radiographic evidence of OA of the knee, defined as presence of osteophytes or joint space narrowing
- Symptomatic OA of the knee or hip was determined at the Baseline Visit, if the Patient's Assessment of Arthritis Pain was at least 40 mm VAS, Patient's and the Physician's Global Assessment of Arthritis was "poor" or "very poor"
Exclusion
- Use of NSAIDs or analgesics within 2 days (within 4 days for subjects taking oxaprozin, piroxicam or full dose aspirin) before baseline arthritis assessments
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00648258
Start Date
July 1 2003
End Date
April 1 2004
Last Update
December 5 2018
Active Locations (4)
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1
Pfizer Investigational Site
Kweishan, Taoyuan, Taiwan
2
Pfizer Investigational Site
Kaohsiung City, Taiwan
3
Pfizer Investigational Site
Taichung, Taiwan
4
Pfizer Investigational Site
Taipei, Taiwan