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:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00650624
First received: March 31, 2008
Last updated: April 7, 2008
Last verified: March 2008
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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:
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 |
|---|---|
| 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
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 Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on June 18, 2013