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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00139776 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis, Knee Osteoarthritis, Hip |
Drug: Celecoxib |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| 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 |
| Enrollment: | 875 |
| Study Start Date: | July 2005 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Celecoxib - Continuous use: Active Comparator |
Drug: Celecoxib
24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind celecoxib 200 mg daily. Placebo used as flare medication when directed. |
| Celecoxib - Intermittent use: Active Comparator |
Drug: Celecoxib
24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind placebo daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed. |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Pfizer Investigational Site | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Pfizer Investigational Site | |
| Peoria, Arizona, United States, 85381 | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85051 | |
| United States, California | |
| Pfizer Investigational Site | |
| Long Beach, California, United States, 90806 | |
| Pfizer Investigational Site | |
| Orange, California, United States, 92868 | |
| Pfizer Investigational Site | |
| Paramount, California, United States, 90723 | |
| Pfizer Investigational Site | |
| Tustin, California, United States, 92780 | |
| Pfizer Investigational Site | |
| Walnut Creek, California, United States, 94598 | |
| Pfizer Investigational Site | |
| Stockton, California, United States, 95204 | |
| Pfizer Investigational Site | |
| Whittier, California, United States, 90601 | |
| Pfizer Investigational Site | |
| Anaheim, California, United States, 92801 | |
| Pfizer Investigational Site | |
| Huntington Beach, California, United States, 92646 | |
| United States, Colorado | |
| Pfizer Investigational Site | |
| Wheatridge, Colorado, United States, 80033 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| Waterbury, Connecticut, United States, 06708 | |
| Pfizer Investigational Site | |
| Danbury, Connecticut, United States, 06810 | |
| Pfizer Investigational Site | |
| New Milford, Connecticut, United States, 06776 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33614-7118 | |
| Pfizer Investigational Site | |
| Zephyrhills, Florida, United States, 33542 | |
| Pfizer Investigational Site | |
| South Miami, Florida, United States, 33143 | |
| Pfizer Investigational Site | |
| Palm Harbor, Florida, United States, 34684 | |
| Pfizer Investigational Site | |
| Ocala, Florida, United States, 34474 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Springfield, Illinois, United States, 62704 | |
| United States, Iowa | |
| Pfizer Investigational Site | |
| Dubuque, Iowa, United States, 52001-7313 | |
| Pfizer Investigational Site | |
| Dubuque, Iowa, United States, 52002 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Lexington, Kentucky, United States, 40509 | |
| Pfizer Investigational Site | |
| Madisonville, Kentucky, United States, 42431 | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Frederick, Maryland, United States, 21702 | |
| Pfizer Investigational Site | |
| Clinton, Maryland, United States, 20735 | |
| Pfizer Investigational Site | |
| Greenbelt, Maryland, United States, 20770 | |
| Pfizer Investigational Site | |
| Baltimore, Maryland, United States, 21218 | |
| Pfizer Investigational Site | |
| Wheaton, Maryland, United States, 20902 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Brockton, Massachusetts, United States, 02301 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| Jefferson City, Missouri, United States, 65101 | |
| Pfizer Investigational Site | |
| Jefferson City, Missouri, United States, 65109 | |
| Pfizer Investigational Site | |
| Springfield, Missouri, United States, 65807 | |
| United States, Nebraska | |
| Pfizer Investigational Site | |
| Omaha, Nebraska, United States, 68134 | |
| Pfizer Investigational Site | |
| Lincoln, Nebraska, United States, 68516 | |
| United States, Nevada | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89106 | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89144 | |
| United States, New York | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10022-1009 | |
| Pfizer Investigational Site | |
| Manlius, New York, United States, 13104 | |
| Pfizer Investigational Site | |
| Great Neck, New York, United States, 11021 | |
| Pfizer Investigational Site | |
| Rochester, New York, United States, 14609 | |
| Pfizer Investigational Site | |
| Mineola, New York, United States, 11501 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Winston Salem, North Carolina, United States, 27103-4019 | |
| Pfizer Investigational Site | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cleveland, Ohio, United States, 44122 | |
| Pfizer Investigational Site | |
| Zanesville, Ohio, United States, 43701 | |
| Pfizer Investigational Site | |
| Columbus, Ohio, United States, 43210-1228 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Eugene, Oregon, United States, 97401 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Philadephia, Pennsylvania, United States, 19152 | |
| Pfizer Investigational Site | |
| Johnstown, Pennsylvania, United States, 15904 | |
| Pfizer Investigational Site | |
| Beaver, Pennsylvania, United States, 15009 | |
| Pfizer Investigational Site | |
| Duncansville, Pennsylvania, United States, 16635-0909 | |
| Pfizer Investigational Site | |
| Camp Hill, Pennsylvania, United States, 17011 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Knoxville, Tennessee, United States, 37920 | |
| Pfizer Investigational Site | |
| Johnson City, Tennessee, United States, 37601 | |
| Pfizer Investigational Site | |
| New Tazewell, Tennessee, United States, 37825 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75235 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75231 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Arlington, Virginia, United States, 22205 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Yakima, Washington, United States, 98902 | |
| Pfizer Investigational Site | |
| Yakima, Washington, United States, 98902-4876 | |
| Pfizer Investigational Site | |
| Renton, Washington, United States, 98055 | |
| Pfizer Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Milwaukee, Wisconsin, United States, 53209 | |
| Belgium | |
| Pfizer Investigational Site | |
| Liege, Belgium, 4000 | |
| Pfizer Investigational Site | |
| Ham, Belgium, 3945 | |
| Brazil, RS | |
| Pfizer Investigational Site | |
| Porto Alegre, RS, Brazil, 90610-000 | |
| Pfizer Investigational Site | |
| Porto Alegre, RS, Brazil, 90035-903 | |
| Brazil, SP | |
| Pfizer Investigational Site | |
| Campinas, SP, Brazil, 13073-350 | |
| Pfizer Investigational Site | |
| São Paulo, SP, Brazil, 04027-000 | |
| Canada, Alberta | |
| Pfizer Investigational Site | |
| Calgary, Alberta, Canada, T2S 2S7 | |
| Canada, British Columbia | |
| Pfizer Investigational Site | |
| Vancouver, British Columbia, Canada, V5K 1K3 | |
| Canada, Newfoundland and Labrador | |
| Pfizer Investigational Site | |
| St. John's, Newfoundland and Labrador, Canada, A1A 3R5 | |
| Pfizer Investigational Site | |
| St. John's, Newfoundland and Labrador, Canada, A1E 2E2 | |
| Pfizer Investigational Site | |
| St. John's, Newfoundland and Labrador, Canada, A1E 2C2 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| North York, Ontario, Canada, M3M 3E5 | |
| Pfizer Investigational Site | |
| Hamilton, Ontario, Canada, L8M 1K7 | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M9W 4L6 | |
| Pfizer Investigational Site | |
| Sarnia, Ontario, Canada, N7T 4X3 | |
| Pfizer Investigational Site | |
| Newmarket, Ontario, Canada, L3Y 5G8 | |
| Pfizer Investigational Site | |
| London, Ontario, Canada, N6C 5J1 | |
| Pfizer Investigational Site | |
| Windsor, Ontario, Canada, N8X 5A6 | |
| Pfizer Investigational Site | |
| Corunna, Ontario, Canada, N0N 1G0 | |
| Canada, Prince Edward Island | |
| Pfizer Investigational Site | |
| Montague, Prince Edward Island, Canada, C0A 1R0 | |
| Pfizer Investigational Site | |
| Charlottetown, Prince Edward Island, Canada, C1A 5Y9 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H4N 2W2 | |
| Pfizer Investigational Site | |
| Rimouski, Quebec, Canada, G5L 9A8 | |
| Pfizer Investigational Site | |
| Ste-Foy, Quebec, Canada, G1W 4R4 | |
| Pfizer Investigational Site | |
| Mirabel, Quebec, Canada, J7J 2K8 | |
| Pfizer Investigational Site | |
| Sherbrooke, Quebec, Canada, J1H 1Z1 | |
| Canada, Saskatchewan | |
| Pfizer Investigational Site | |
| Saskatoon, Saskatchewan, Canada, S7K 0H6 | |
| Chile, RM | |
| Pfizer Investigational Site | |
| Santiago, RM, Chile | |
| Chile, V Region | |
| Pfizer Investigational Site | |
| Viña Del Mar, V Region, Chile | |
| Chile, VI Región | |
| Pfizer Investigational Site | |
| Rancagua, VI Región, Chile | |
| Colombia | |
| Pfizer Investigational Site | |
| Bucaramanga, Colombia | |
| Pfizer Investigational Site | |
| Barranquila, Colombia | |
| Pfizer Investigational Site | |
| Bogota, Colombia | |
| Colombia, Cundinamarca | |
| Pfizer Investigational Site | |
| Bogota, Cundinamarca, Colombia | |
| France | |
| Pfizer Investigational Site | |
| Tours, France, 37000 | |
| Pfizer Investigational Site | |
| Joue Les Tours, France, 37300 | |
| Pfizer Investigational Site | |
| Poitiers, France, 86000 | |
| Pfizer Investigational Site | |
| L'Union, France, 31240 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Blackpool, United Kingdom, FY4 3AD | |
| Pfizer Investigational Site | |
| BATH, United Kingdom, BA2 4BY | |
| Pfizer Investigational Site | |
| Trowbridge, United Kingdom, BA14 9AR | |
| Pfizer Investigational Site | |
| Cardiff, United Kingdom, CF24 2HP | |
| Pfizer Investigational Site | |
| Bangor, United Kingdom, BT19 1PP | |
| Pfizer Investigational Site | |
| Cookstown, United Kingdom, BT80 8BG | |
| Pfizer Investigational Site | |
| Belfast, United Kingdom, BT14 6AR | |
| United Kingdom, Co Antrim | |
| Pfizer Investigational Site | |
| Randalstown, Co Antrim, United Kingdom, BT41 3AE | |
| United Kingdom, Co.Antrim | |
| Pfizer Investigational Site | |
| Newtownabbey, Co.Antrim, United Kingdom, BT37 9QN | |
| United Kingdom, Fife | |
| Pfizer Investigational Site | |
| Leslie, Fife, United Kingdom, KY6 3LQ | |
| United Kingdom, Herts | |
| Pfizer Investigational Site | |
| Watford, Herts, United Kingdom, WD25 0EA | |
| United Kingdom, Kent | |
| Pfizer Investigational Site | |
| Canterbury, Kent, United Kingdom, CT1 3HX | |
| United Kingdom, Lancs | |
| Pfizer Investigational Site | |
| Wigan, Lancs, United Kingdom, WN6 9EP | |
| United Kingdom, Milton Keynes | |
| Pfizer Investigational Site | |
| Bradwell Common, Milton Keynes, United Kingdom, MK13 8RN | |
| United Kingdom, Northern Ireland | |
| Pfizer Investigational Site | |
| Greenisland, Carrickfergus, Northern Ireland, United Kingdom, BT38 8TP | |
| United Kingdom, Vale of Glamorgan | |
| Pfizer Investigational Site | |
| Barry, Vale of Glamorgan, United Kingdom, CF62 7EB | |
| United Kingdom, West Sussex | |
| Pfizer Investigational Site | |
| Pound Hill, Crawley, West Sussex, United Kingdom, RH10 7DX | |
| United Kingdom, Wiltshire | |
| Pfizer Investigational Site | |
| Midsomer Norton, Wiltshire, United Kingdom, BA3 2UH | |
| Pfizer Investigational Site | |
| Bradford on Avon, Wiltshire, United Kingdom, BA15 1DQ | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A3191173 |
| Study First Received: | August 29, 2005 |
| Results First Received: | February 20, 2009 |
| Last Updated: | June 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00139776 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Chronic treatment osteoarthritis, Celecoxib, Continuous Use, Intermittent Use |
|
Anti-Inflammatory Agents Celecoxib Molecular Mechanisms of Pharmacological Action Osteoarthritis Joint Diseases Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Osteoarthritis, Hip Rheumatic Diseases Pharmacologic Actions |
Osteoarthritis, Knee Musculoskeletal Diseases Sensory System Agents Analgesics, Non-Narcotic Arthritis Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |
