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)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00650624
First received: March 31, 2008
Last updated: April 7, 2008
Last verified: March 2008
  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 2

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:


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
Active Comparator: Arm 1 Drug: valdecoxib
valdecoxib 5 mg tablet by mouth once daily in the morning for 6 weeks
Active Comparator: Arm 2 Drug: valdecoxib
valdecoxib 10 mg tablet by mouth once daily in the morning for 6 weeks
Active Comparator: Arm 3 Drug: valdecoxib
valdecoxib 20 mg tablet by mouth once daily in the morning for 6 weeks
Placebo Comparator: Arm 4 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
Pfizer Investigational Site
Funabashi, Chiba, Japan
Pfizer Investigational Site
Sakura, Chiba, Japan
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
Pfizer Investigational Site
Chitose, Hokkaido, Japan
Pfizer Investigational Site
Sapporo, 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
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
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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
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
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014