To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee and hip...
Date First Received: August 29, 2005
Last Updated: May 21, 2008
Verified by: Pfizer, May 2008
Clinical Trial Phase: Phase 4 | Start Date: July 2005
Overall Status: Completed
Estimated Enrollment: 875
Brief Summary
Official Title: “Double-Blind Parallel-Group Randomized Study Of Efficacy And Safety Of "Continuous Use" Of Celecoxib Vs. The "Usual Use" Of Celecoxib In The Treatment Of Subjects With Chronic Osteoarthritis Of The Hip Or Knee Who Require an Anti-Inflammatory Medication for Control Of Their Pain”
Condition Keyword(s):
Intervention(s):
To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee and hip.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Outcome Measures for this Clinical Trial
Primary:
- To determine whether "continuous use" over a 6-month period of celecoxib 200 mg per day is more efficacious than "intermittent use" of celecoxib 200 mg per day in reducing the number of spontaneous osteoarthritis flares of the knee or hip joints. 6 months No
Secondary:
- Amount of study flare medication taken 6 months No
- Time to first arthritis flare from the first dose of study medication 6 months No
- Number of days a subject is free from arthritis flare 6 months No
- Number of days a subject is in arthritis flare 6 months No
- Medical Outcomes Study Sleep Scale 6 months No
- Patient's Assessment of Arthritis Pain 6 months No
- Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index 6 months No
- Patient's Global Assessment of Arthritis 6 months No
- Physician's Global Assessment of Arthritis 6 months No
- Amount of rescue medication (paracetamol/acetaminophen) taken 6 months No
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Subject has been diagnosed, according to American College of Rheumatology guidelines, with osteoarthritis of the hip or knee and requires NSAIDs to control their osteoarthritis pain and have access to a touch-tone telephone.
Exclusion Criteria:
- Subject has had surgery on index joint.
- Subject has history of rheumatoid arthritis or fibromyalgia syndrome.
- Subject has active gastrointestinal or cardiovascular disease.
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Pfizer
Pfizer Investigational Site
Huntsville Alabama 35801 United States
Pfizer Investigational Site
Peoria Arizona 85381 United States
Pfizer Investigational Site
Phoenix Arizona 85051 United States
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Tustin California 92780 United States
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Orange California 92868 United States
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Paramount California 90723 United States
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Long Beach California 90806 United States
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Walnut Creek California 94598 United States
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Stockton California 95204 United States
Pfizer Investigational Site
Whittier California 90601 United States
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Anaheim California 92801 United States
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Huntington Beach California 92646 United States
Pfizer Investigational Site
Wheatridge Colorado 80033 United States
Pfizer Investigational Site
Waterbury Connecticut 06708 United States
Pfizer Investigational Site
Danbury Connecticut 06810 United States
Pfizer Investigational Site
New Milford Connecticut 06776 United States
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Tampa Florida 33614-7118 United States
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Zephyrhills Florida 33542 United States
Pfizer Investigational Site
South Miami Florida 33143 United States
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Palm Harbor Florida 34684 United States
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Ocala Florida 34474 United States
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Decatur Georgia 30033 United States
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Springfield Illinois 62704 United States
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Dubuque Iowa 52001-7313 United States
Pfizer Investigational Site
Dubuque Iowa 52002 United States
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Lexington Kentucky 40509 United States
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Madisonville Kentucky 42431 United States
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Baltimore Maryland 21218 United States
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Clinton Maryland 20735 United States
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Greenbelt Maryland 20770 United States
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Frederick Maryland 21702 United States
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Wheaton Maryland 20902 United States
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Brockton Massachusetts 02301 United States
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Jefferson City Missouri 65101 United States
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Jefferson City Missouri 65109 United States
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Springfield Missouri 65807 United States
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Omaha Nebraska 68134 United States
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Lincoln Nebraska 68516 United States
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Las Vegas Nevada 89106 United States
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Las Vegas Nevada 89144 United States
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New York New York 10022-1009 United States
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Manlius New York 13104 United States
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Great Neck New York 11021 United States
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Rochester New York 14609 United States
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Mineola New York 11501 United States
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Winston Salem North Carolina 27103-4019 United States
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Winston-Salem North Carolina 27103 United States
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Cleveland Ohio 44122 United States
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Zanesville Ohio 43701 United States
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Columbus Ohio 43210-1228 United States
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Eugene Oregon 97401 United States
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Duncansville Pennsylvania 16635-0909 United States
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Johnstown Pennsylvania 15904 United States
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Beaver Pennsylvania 15009 United States
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Philadephia Pennsylvania 19152 United States
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Camp Hill Pennsylvania 17011 United States
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Knoxville Tennessee 37920 United States
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Johnson City Tennessee 37601 United States
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New Tazewell Tennessee 37825 United States
Pfizer Investigational Site
Dallas Texas 75235 United States
Pfizer Investigational Site
Dallas Texas 75231 United States
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Arlington Virginia 22205 United States
Pfizer Investigational Site
Yakima Washington 98902 United States
Pfizer Investigational Site
Yakima Washington 98902-4876 United States
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Renton Washington 98055 United States
Pfizer Investigational Site
Tacoma Washington 98405 United States
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Milwaukee Wisconsin 53209 United States
Pfizer Investigational Site
Liege 4000 Belgium
Pfizer Investigational Site
Ham 3945 Belgium
Pfizer Investigational Site
Porto Alegre RS 90610-000 Brazil
Pfizer Investigational Site
Porto Alegre RS 90035-903 Brazil
Pfizer Investigational Site
Campinas SP 13073-350 Brazil
Pfizer Investigational Site
São Paulo SP 04027-000 Brazil
Pfizer Investigational Site
Calgary Alberta T2S 2S7 Canada
Pfizer Investigational Site
Vancouver British Columbia V5K 1K3 Canada
Pfizer Investigational Site
St. John's Newfoundland and Labrador A1A 3R5 Canada
Pfizer Investigational Site
St. John's Newfoundland and Labrador A1E 2E2 Canada
Pfizer Investigational Site
St. John's Newfoundland and Labrador A1E 2C2 Canada
Pfizer Investigational Site
North York Ontario M3M 3E5 Canada
Pfizer Investigational Site
Hamilton Ontario L8M 1K7 Canada
Pfizer Investigational Site
Toronto Ontario M9W 4L6 Canada
Pfizer Investigational Site
Sarnia Ontario N7T 4X3 Canada
Pfizer Investigational Site
Corunna Ontario N0N 1G0 Canada
Pfizer Investigational Site
London Ontario N6C 5J1 Canada
Pfizer Investigational Site
Windsor Ontario N8X 5A6 Canada
Pfizer Investigational Site
Newmarket Ontario L3Y 5G8 Canada
Pfizer Investigational Site
Montague Prince Edward Island C0A 1R0 Canada
Pfizer Investigational Site
Charlottetown Prince Edward Island C1A 5Y9 Canada
Pfizer Investigational Site
Montreal Quebec H4N 2W2 Canada
Pfizer Investigational Site
Rimouski Quebec G5L 9A8 Canada
Pfizer Investigational Site
Sherbrooke Quebec J1H 1Z1 Canada
Pfizer Investigational Site
Mirabel Quebec J7J 2K8 Canada
Pfizer Investigational Site
Ste-Foy Quebec G1W 4R4 Canada
Pfizer Investigational Site
Saskatoon Saskatchewan S7K 0H6 Canada
Pfizer Investigational Site
Santiago RM Chile
Pfizer Investigational Site
Viña Del Mar V Region Chile
Pfizer Investigational Site
Rancagua VI Región Chile
Pfizer Investigational Site
Bucaramanga Colombia
Pfizer Investigational Site
Barranquila Colombia
Pfizer Investigational Site
Bogota Colombia
Pfizer Investigational Site
Bogota Cundinamarca Colombia
Pfizer Investigational Site
Tours 37000 France
Pfizer Investigational Site
Joue Les Tours 37300 France
Pfizer Investigational Site
Poitiers 86000 France
Pfizer Investigational Site
L'Union 31240 France
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Cardiff CF24 2HP United Kingdom
Pfizer Investigational Site
BATH BA2 4BY United Kingdom
Pfizer Investigational Site
Trowbridge BA14 9AR United Kingdom
Pfizer Investigational Site
Blackpool FY4 3AD United Kingdom
Pfizer Investigational Site
Bangor BT19 1PP United Kingdom
Pfizer Investigational Site
Cookstown BT80 8BG United Kingdom
Pfizer Investigational Site
Belfast BT14 6AR United Kingdom
Pfizer Investigational Site
Randalstown Co Antrim BT41 3AE United Kingdom
Pfizer Investigational Site
Newtownabbey Co.Antrim BT37 9QN United Kingdom
Pfizer Investigational Site
Leslie Fife KY6 3LQ United Kingdom
Pfizer Investigational Site
Watford Herts WD25 0EA United Kingdom
Pfizer Investigational Site
Canterbury Kent CT1 3HX United Kingdom
Pfizer Investigational Site
Wigan Lancs WN6 9EP United Kingdom
Pfizer Investigational Site
Bradwell Common Milton Keynes MK13 8RN United Kingdom
Pfizer Investigational Site
Greenisland, Carrickfergus Northern Ireland BT38 8TP United Kingdom
Pfizer Investigational Site
Barry Vale of Glamorgan CF62 7EB United Kingdom
Pfizer Investigational Site
Pound Hill, Crawley West Sussex RH10 7DX United Kingdom
Pfizer Investigational Site
Midsomer Norton Wiltshire BA3 2UH United Kingdom
Pfizer Investigational Site
Bradford on Avon Wiltshire BA15 1DQ United Kingdom
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on July 23, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00139776
Study ID Number: A3191173
ClinicalTrials.gov Identifier: NCT00139776
Health Authority: United States: Food and Drug Administration
To obtain contact information for a study center near you, click here.
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
