Status:
COMPLETED
Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Osteoarthritis of the Knee
Lead Sponsor:
Pfizer
Conditions:
Osteoarthritis
Knee
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study was performed to demonstrate that treatment with valdecoxib 10 mg daily (QD) was at least as effective as with naproxen 500 mg twice daily (BID), a standard non-steroidal anti-inflammatory ...
Eligibility Criteria
Inclusion
- Korean outpatients with symptomatic radiologic evidence of OA of the knee (diagnosed according to the modified American College Rheumatology criteria)
- Patient's Assessment of Arthritis Pain measurement of at least 40 mm on VAS
- Patients had not received any NSAIDs or analgesics within 2 days (within 4 days for subjects taking oxaprozin, piroxicam or full dose aspirin) prior to the Baseline Visit
Exclusion
- Diagnosis of inflammatory arthritis, gout, pseudogout, Paget's disease, or any chronic pain syndrome that, in the Investigator's opinion, would interfere with the assessment of the Index Knee
- Symptomatic anserine bursitis or acute joint trauma of the Index Knee
- Arthroscopy performed on the Index Knee within the past 12 months
- Complete loss of articular cartilage of the Index Knee
- Administration of oral, or intramuscular, intravenous, or soft tissue injections of corticosterosteroids within 4 weeks prior to screening visit
- Administration of intra-articular injection of corticosteroids or hyaluronic acid preparation in the Index Knee within 3 months or 6 months, respectively
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT00652808
Start Date
May 1 2004
End Date
September 1 2004
Last Update
April 10 2008
Active Locations (8)
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1
Pfizer Investigational Site
Anyang, South Korea, 431-070
2
Pfizer Investigational Site
Gwangju, South Korea, 501-757
3
Pfizer Investigational Site
Incheon, South Korea, 405-760
4
Pfizer Investigational Site
Pusan, South Korea, 602-739