Official Title: “A Double-Blind, Double Dummy, Randomized Comparison Study Of The Efficacy And Safety Of Valdecoxib 10mg QD And Naproxen 500mg BID In Treating The Signs And Symptoms Of Osteoarthritis Of The Knee Or Hip In Taiwan”

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 (OA) of the knee or hip. The study was designed to collect comparative information for the local population (Taiwan).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), 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 (Osteoarthritis-Pain VAS)
  • Time Frame: Week 6
    Safety Issue?: No

Secondary Measures

• Western Ontario and McMaster Universities Osteoarthritis (WOMAC OA) Composite Index
  • Time Frame: Week 2 and Week 6
    Safety Issue?: No
• WOMAC OA physical function
  • Time Frame: Week 2 and Week 6
    Safety Issue?: No
• WOMAC OA pain index
  • 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 (Osteoarthritis-Pain VAS)
  • Time Frame: Week 2
    Safety Issue?: No
• Patient's Global Assessment of Arthritis
  • Time Frame: Week 2 and Week 6
    Safety Issue?: No
• Physician's Global Assessment of Arthritis
  • Time Frame: Week 2 and Week 6
    Safety Issue?: No

Inclusion Criteria:

• 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 Criteria:

• Use of NSAIDs or analgesics within 2 days (within 4 days for subjects taking oxaprozin, piroxicam or full dose aspirin) before baseline arthritis assessments

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 September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00648258

Study ID Number: VALA-0513-141

ClinicalTrials.gov Identifier: NCT00648258

Health Authority: Taiwan: Department of Health

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org posting: