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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Valdecoxib

U.S. FDA Resources

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, Chiba
Pfizer Investigational Site
Funabashi, Chiba, Japan
Pfizer Investigational Site
Sakura, Chiba, Japan
Japan, Fukuoka
Pfizer Investigational Site
Chikushi-gun, Fukuoka, Japan
Pfizer Investigational Site
Iizuka, Fukuoka, Japan
Pfizer Investigational Site
Kurume, Fukuoka, Japan
Pfizer Investigational Site
Yame, Fukuoka, Japan
Japan, Hokkaido
Pfizer Investigational Site
Chitose, Hokkaido, Japan
Pfizer Investigational Site
Sapporo, 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
Itabashi-ku, Tokyo, Japan
Pfizer Investigational Site
Setagaya-ku, Tokyo, Japan
Pfizer Investigational Site
Shinjuku-Ku, Tokyo, Japan
Pfizer Investigational Site
Taito-ku, Tokyo, Japan
Japan
Pfizer Investigational Site
Saga, Japan
Pfizer Investigational Site
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 )
ClinicalTrials.gov Identifier:	NCT00650624 History of Changes
Other Study ID Numbers:	VALAJP-8274-156, A3471090
Study First Received:	March 31, 2008
Last Updated:	April 7, 2008
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:

knee osteoarthritis; Japan

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Valdecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 02, 2010