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

Overview

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).

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)

Interventions

  • 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

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

Clinical Trial Outcome Measures

Primary Measures

  • Patient’s Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)
    • Time Frame: Week 6

Secondary Measures

  • Western Ontario and McMaster Universities Osteoarthritis (WOMAC OA) Composite Index
    • Time Frame: Week 2 and Week 6
  • WOMAC OA physical function
    • Time Frame: Week 2 and Week 6
  • WOMAC OA pain index
    • Time Frame: Week 2 and Week 6
  • WOMAC OA stiffness index
    • Time Frame: Week 2 and Week 6
  • Patient’s Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)
    • Time Frame: Week 2
  • Patient’s Global Assessment of Arthritis
    • Time Frame: Week 2 and Week 6
  • Physician’s Global Assessment of Arthritis
    • Time Frame: Week 2 and Week 6

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Director, Clinical Trial Disclosure Group, Pfizer, Inc.
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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