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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

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Anyang, , 431-070 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis, Knee
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT00652808
Pfizer
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

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