A Dose-Ranging Study Of Valdecoxib 5 Mg, 10 Mg, And 20 Mg Once Daily Versus Placebo In Patients With Osteoarthritis Of The Knee (Japan)
- Registration Number
- NCT00650624
- Lead Sponsor
- Pfizer
- Brief Summary
To determine the therapeutic dose range of valdecoxib by comparing the efficacy of three dosing regimens (5 mg, 10 mg and 20 mg once daily) with placebo for relief of the signs and symptoms of osteoarthritis of the knee. To assess safety and tolerability of multiple doses of valdecoxib in patients with osteoarthritis of the knee.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 416
Inclusion Criteria
- Patients diagnosed with symptomatic OA of the knee by the American College of Rheumatology (ACR) criteria and a Functional Capacity Classification (FCC) of I - III at Screening Visit and were walking
- At the Baseline visit, eligible patients were to have Patient's Assessment of Arthritis Pain VAS ≥ 40 mm and Patient's & Physician's Global Assessment of Arthritis of "Poor" or "Very Poor"
Exclusion Criteria
- Patients unable to walk generally
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 valdecoxib - Arm 4 placebo - Arm 2 valdecoxib - Arm 3 valdecoxib -
- Primary Outcome Measures
Name Time Method WOMAC (Western Ontario and McMaster Universities) OA Pain Index screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 (final visit)
- Secondary Outcome Measures
Name Time Method patient's assessment of arthritis pain (Visual Analog Scale, VAS) screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 WOMAC OA composite index screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 WOMAC OA pain index, stiffness index, physical function index, and composite index screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 Incidence of and time to withdrawal due to lack of efficacy weeks 2, 4, and 6 patients' and physicians' and 'categorical' global assessment of arthritis screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 WOMAC OA physical function index screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 WOMAC OA stiffness index screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇯🇵Tokyo, Japan