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Completed

NCT Number: NCT00648258

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

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).

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis, Hip Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Kweishan, Taoyuan, Taiwan

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Who can participate

Healthy volunteers accepted: No

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

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

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 (Osteoarthritis-Pain VAS)

    Time frame: Week 6

Secondary outcomes

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

    Time frame: Week 2 and Week 6

  2. WOMAC OA physical function

    Time frame: Week 2 and Week 6

  3. WOMAC OA pain index

    Time frame: Week 2 and Week 6

  4. WOMAC OA stiffness index

    Time frame: Week 2 and Week 6

  5. Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)

    Time frame: Week 2

  6. Patient's Global Assessment of Arthritis

    Time frame: Week 2 and Week 6

  7. Physician's Global Assessment of Arthritis

    Time frame: Week 2 and Week 6

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2004
First posted
Apr 1, 2008
Registry last updated
Dec 5, 2018

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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