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) - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00650624

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis, Knee	Drug: valdecoxib Drug: placebo	Phase II

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Valdecoxib

U.S. FDA Resources

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

Further study details as provided by Pfizer:

Primary Outcome 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) ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
WOMAC OA stiffness index [ Time Frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 ] [ Designated as safety issue: No ]
WOMAC OA physical function index [ Time Frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 ] [ Designated as safety issue: No ]
WOMAC OA composite index [ Time Frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 ] [ Designated as 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 ] [ Designated as safety issue: No ]
Incidence of and time to withdrawal due to lack of efficacy [ Time Frame: weeks 2, 4, and 6 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Enrollment:	416
Study Start Date:	June 2003
Study Completion Date:	January 2004

Arms	Assigned Interventions
Arm 1: Active Comparator	Drug: valdecoxib valdecoxib 5 mg tablet by mouth once daily in the morning for 6 weeks
Arm 2: Active Comparator	Drug: valdecoxib valdecoxib 10 mg tablet by mouth once daily in the morning for 6 weeks
Arm 3: Active Comparator	Drug: valdecoxib valdecoxib 20 mg tablet by mouth once daily in the morning for 6 weeks
Arm 4: Placebo Comparator	Drug: placebo placebo tablet by mouth once daily in the morning for 6 weeks

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650624

Locations

Japan
Pfizer Investigational Site
Saga, Japan
Pfizer Investigational Site
Tokyo, Japan
Japan, Chiba
Pfizer Investigational Site
Funabashi, Chiba, Japan
Pfizer Investigational Site
Sakura, Chiba, Japan
Japan, Fukuoka
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
Japan, Hokkaido
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Chitose, Hokkaido, Japan
Japan, Kanagawa
Pfizer Investigational Site
Kamakura, Kanagawa, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Japan, Nagasaki
Pfizer Investigational Site
Isahaya, Nagasaki, Japan
Japan, Osaka
Pfizer Investigational Site
Hirakata, Osaka, Japan
Japan, Saga
Pfizer Investigational Site
Kanzaki-gun, Saga, Japan
Pfizer Investigational Site
Karatsu, Saga, Japan
Pfizer Investigational Site
Ogi-gun, Saga, Japan
Japan, Tokyo
Pfizer Investigational Site
2-7-8 Yoyogi Shibuya-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
Itabashi-ku, Tokyo, Japan

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting: This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	VALAJP-8274-156, A3471090
Study First Received:	March 31, 2008
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00650624 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:

knee osteoarthritis; Japan

Study placed in the following topic categories:

Anti-Inflammatory Agents
Osteoarthritis
Joint Diseases
Cyclooxygenase Inhibitors
Rheumatic Diseases
Osteoarthritis, Knee
Musculoskeletal Diseases

Analgesics, Non-Narcotic
Arthritis
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Valdecoxib
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Osteoarthritis
Joint Diseases
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Rheumatic Diseases
Pharmacologic Actions
Osteoarthritis, Knee
Musculoskeletal Diseases

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Arthritis
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Valdecoxib
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009