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

Overview

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.

Full Title of Study: “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”

Study Type

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

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 using a Visual Analogue Scale (OA-Pain VAS)
    • Time Frame: Week 6

Secondary Measures

  • WOMAC OA Physical Function
    • Time Frame: Week 2 and Week 6
  • WOMAC OA Stiffness Index
    • Time Frame: Week 2 and Week 6
  • Patient’s Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
    • Time Frame: Week 2
  • Patient’s Global Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
    • Time Frame: Week 2 and Week 6
  • adverse events
    • Time Frame: Continuous
  • Physician’s Global Assessment of Arthritis Pain
    • Time Frame: Week 2 and Week 6
  • WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Osteoarthritis (OA) Composite Index
    • Time Frame: Week 2 and Week 6
  • WOMAC OA Pain Index
    • Time Frame: Week 2 and Week 6

Participating in This Clinical Trial

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: 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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.