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

Primary:

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

Secondary:

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

Lead Sponsor: Pfizer

Pfizer Investigational Site

Saga   Japan

Pfizer Investigational Site

Tokyo   Japan

Pfizer Investigational Site

Funabashi Chiba  Japan

Pfizer Investigational Site

Sakura Chiba  Japan

Pfizer Investigational Site

Kurume Fukuoka  Japan

Pfizer Investigational Site

Yame Fukuoka  Japan

Pfizer Investigational Site

Iizuka Fukuoka  Japan

Pfizer Investigational Site

Chikushi-gun Fukuoka  Japan

Pfizer Investigational Site

Sapporo Hokkaido  Japan

Pfizer Investigational Site

Chitose Hokkaido  Japan

Pfizer Investigational Site

Kamakura Kanagawa  Japan

Pfizer Investigational Site

Yokohama Kanagawa  Japan

Pfizer Investigational Site

Isahaya Nagasaki  Japan

Pfizer Investigational Site

Hirakata Osaka  Japan

Pfizer Investigational Site

Kanzaki-gun Saga  Japan

Pfizer Investigational Site

Karatsu Saga  Japan

Pfizer Investigational Site

Ogi-gun Saga  Japan

Pfizer Investigational Site

Itabashi-ku Tokyo  Japan

Pfizer Investigational Site

Taito-ku Tokyo  Japan

Pfizer Investigational Site

Shinjuku-Ku Tokyo  Japan

Pfizer Investigational Site

Shinjuku-ku Tokyo  Japan

Pfizer Investigational Site

Setagaya-ku Tokyo  Japan

Pfizer Investigational Site

2-7-8 Yoyogi Shibuya-ku Tokyo  Japan

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 23, 2008

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

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org posting: