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)

Condition(s) targeted: Osteoarthritis, Knee

Intervention: valdecoxib (Drug); valdecoxib (Drug); valdecoxib (Drug); placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

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

Primary outcome: WOMAC (Western Ontario and McMaster Universities) OA Pain Index

Secondary outcome:

patients' and physicians' and 'categorical' global assessment of arthritis

WOMAC OA stiffness index

WOMAC OA physical function index

WOMAC OA composite index

WOMAC OA stiffness index

WOMAC OA pain index, stiffness index, physical function index, and composite index

Incidence of and time to withdrawal due to lack of efficacy

patient's assessment of arthritis pain (Visual Analog Scale, VAS)

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

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

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

Link to ClinicalStudyResults.org posting:

Starting date: June 2003
Ending date: January 2004
Last updated: April 7, 2008