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)

Study Overview
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Brief Summary
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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.

Official Title
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A Dose-Ranging Study Of Valdecoxib 5 Mg, 10 Mg, And 20 Mg QD Versus Placebo In Patients With OA Of The Knee

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: valdecoxib
* Drug: valdecoxib
* Drug: valdecoxib
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: valdecoxib<br>* valdecoxib 5 mg tablet by mouth once daily in the morning for 6 weeks<br>|
| Active Comparator: Arm 2<br> | Drug: valdecoxib<br>* valdecoxib 10 mg tablet by mouth once daily in the morning for 6 weeks<br>|
| Active Comparator: Arm 3<br> | Drug: valdecoxib<br>* valdecoxib 20 mg tablet by mouth once daily in the morning for 6 weeks<br>|
| Placebo Comparator: Arm 4<br> | Drug: placebo<br>* placebo tablet by mouth once daily in the morning for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients' and physicians' and 'categorical' global assessment of arthritis |  | 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 | 
| WOMAC OA physical function index |  | 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 | 
| patient's assessment of arthritis pain (Visual Analog Scale, VAS) |  | screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee osteoarthritis; Japan