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NCT Number: NCT00652808

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Knee Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Anyang, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

valdecoxib

Drug

valdecoxib 10 mg tablet by mouth once daily for 6 weeks

Naproxen

Drug

naproxen 500 mg capsule by mouth twice daily for 6 weeks

Primary outcomes

  1. Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)

    Time frame: Week 6

Secondary outcomes

  1. WOMAC OA Physical Function

    Time frame: Week 2 and Week 6

  2. WOMAC OA Stiffness Index

    Time frame: Week 2 and Week 6

  3. Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)

    Time frame: Week 2

  4. Patient's Global Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)

    Time frame: Week 2 and Week 6

  5. adverse events

    Time frame: Continuous

  6. Physician's Global Assessment of Arthritis Pain

    Time frame: Week 2 and Week 6

  7. WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Osteoarthritis (OA) Composite Index

    Time frame: Week 2 and Week 6

  8. WOMAC OA Pain Index

    Time frame: Week 2 and Week 6

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2004
First posted
Apr 4, 2008
Registry last updated
Apr 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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