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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: valdecoxib
  • valdecoxib 5 mg tablet by mouth once daily in the morning for 6 weeks
• Drug: valdecoxib
  • valdecoxib 10 mg tablet by mouth once daily in the morning for 6 weeks
• Drug: valdecoxib
  • valdecoxib 20 mg tablet by mouth once daily in the morning for 6 weeks
• Drug: placebo
  • placebo tablet by mouth once daily in the morning for 6 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 1
• Active Comparator: Arm 2
• Active Comparator: Arm 3
• Placebo Comparator: Arm 4

Primary Measures

• WOMAC (Western Ontario and McMaster Universities) OA Pain Index
  • Time Frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 (final visit)
    Safety Issue?: No

Secondary Measures

• patients' and physicians' and 'categorical' global assessment of arthritis
  • Time Frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
    Safety Issue?: No
• WOMAC OA stiffness index
  • Time Frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
    Safety Issue?: No
• WOMAC OA physical function index
  • Time Frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
    Safety Issue?: No
• WOMAC OA composite index
  • Time Frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
    Safety Issue?: No
• WOMAC OA stiffness index
  • Time Frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
    Safety Issue?: No
• WOMAC OA pain index, stiffness index, physical function index, and composite index
  • Time Frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
    Safety Issue?: No
• Incidence of and time to withdrawal due to lack of efficacy
  • Time Frame: weeks 2, 4, and 6
    Safety Issue?: No
• patient's assessment of arthritis pain (Visual Analog Scale, VAS)
  • Time Frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00650624

Study ID Number: VALAJP-8274-156

ClinicalTrials.gov Identifier: NCT00650624

Health Authority: Japan: Ministry of Health, Labor and Welfare

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