Official Title: “Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg QD and Naproxen 500 mg BID in Treating the Signs and Symptoms of Osteoarthritis of the Knee”

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 drug (NSAID), when taken for 6 weeks in Korean subjects with symptomatic osteoarthritis (OA) of the knee. Secondary objectives were to assess the overall safety and tolerability of valdecoxib 10 mg QD taken for 6 weeks in Korean subjects with symptomatic OA of the knee.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: valdecoxib
  • valdecoxib 10 mg tablet by mouth once daily for 6 weeks
• Drug: naproxen
  • naproxen 500 mg capsule by mouth twice daily for 6 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 1
• Active Comparator: Arm 2

Primary Measures

• Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
  • Time Frame: Week 6
    Safety Issue?: No

Secondary Measures

• WOMAC OA Physical Function
  • Time Frame: Week 2 and Week 6
    Safety Issue?: No
• WOMAC OA Stiffness Index
  • Time Frame: Week 2 and Week 6
    Safety Issue?: No
• Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
  • Time Frame: Week 2
    Safety Issue?: No
• Patient's Global Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
  • Time Frame: Week 2 and Week 6
    Safety Issue?: No
• adverse events
  • Time Frame: Continuous
    Safety Issue?: Yes
• Physician's Global Assessment of Arthritis Pain
  • Time Frame: Week 2 and Week 6
    Safety Issue?: No
• WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Osteoarthritis (OA) Composite Index
  • Time Frame: Week 2 and Week 6
    Safety Issue?: No
• WOMAC OA Pain Index
  • Time Frame: Week 2 and Week 6
    Safety Issue?: No

Inclusion Criteria:

• 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:

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00652808

Study ID Number: A3471045

ClinicalTrials.gov Identifier: NCT00652808

Health Authority: Unkown: Obtaining information and will provide once confirmed.

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