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Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use"

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoarthritis, Knee; Osteoarthritis, Hip

Intervention: Celecoxib (Drug); Celecoxib (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of Flare Events Per Time of Exposure to Study Medication

Secondary outcome:

Time to Occurrence of First Osteoarthritis (OA) Flare

Proportion of Days Free From Osteoarthritis (OA) Flare

Proportion of Days in Osteoarthritis (OA) Flare

Arthritis Pain Numerical Rating Scale (NRS)

Patient's Global Assessment of Arthritis

Physician's Global Assessment of Arthritis at Final Visit

Total Rescue Medication Taken (Mean)

Proportion of Days on Rescue Medication

Days on Flare Medication

Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores

Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject has been diagnosed, according to American College of Rheumatology guidelines,

with osteoarthritis of the hip or knee and requires non-steroidal anti-inflammatory drugs (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.

Locations and Contacts

Pfizer Investigational Site, Ham 3945, Belgium

Pfizer Investigational Site, Liege 4000, Belgium

Pfizer Investigational Site, Barranquila, Colombia

Pfizer Investigational Site, Bogota, Colombia

Pfizer Investigational Site, Bucaramanga, Colombia

Pfizer Investigational Site, Joue Les Tours 37300, France

Pfizer Investigational Site, L'Union 31240, France

Pfizer Investigational Site, Poitiers 86000, France

Pfizer Investigational Site, Tours 37000, France

Pfizer Investigational Site, Bangor BT19 1PP, United Kingdom

Pfizer Investigational Site, Bath BA2 4BY, United Kingdom

Pfizer Investigational Site, Belfast BT14 6AR, United Kingdom

Pfizer Investigational Site, Blackpool FY4 3AD, United Kingdom

Pfizer Investigational Site, Cardiff CF24 2HP, United Kingdom

Pfizer Investigational Site, Cookstown BT80 8BG, United Kingdom

Pfizer Investigational Site, Trowbridge BA14 9AR, United Kingdom

Pfizer Investigational Site, Huntsville, Alabama 35801, United States

Pfizer Investigational Site, Calgary, Alberta T2S 2S7, Canada

Pfizer Investigational Site, Peoria, Arizona 85381, United States

Pfizer Investigational Site, Phoenix, Arizona 85051, United States

Pfizer Investigational Site, Vancouver, British Columbia V5K 1K3, Canada

Pfizer Investigational Site, Anaheim, California 92801, United States

Pfizer Investigational Site, Huntington Beach, California 92646, United States

Pfizer Investigational Site, Long Beach, California 90806, United States

Pfizer Investigational Site, Orange, California 92868, United States

Pfizer Investigational Site, Paramount, California 90723, United States

Pfizer Investigational Site, Stockton, California 95204, United States

Pfizer Investigational Site, Tustin, California 92780, United States

Pfizer Investigational Site, Walnut Creek, California 94598, United States

Pfizer Investigational Site, Whittier, California 90601, United States

Pfizer Investigational Site, Randalstown, Co Antrim BT41 3AE, United Kingdom

Pfizer Investigational Site, Newtownabbey, Co.Antrim BT37 9QN, United Kingdom

Pfizer Investigational Site, Wheatridge, Colorado 80033, United States

Pfizer Investigational Site, Danbury, Connecticut 06810, United States

Pfizer Investigational Site, New Milford, Connecticut 06776, United States

Pfizer Investigational Site, Waterbury, Connecticut 06708, United States

Pfizer Investigational Site, Bogota, Cundinamarca, Colombia

Pfizer Investigational Site, Leslie, Fife KY6 3LQ, United Kingdom

Pfizer Investigational Site, Ocala, Florida 34474, United States

Pfizer Investigational Site, Palm Harbor, Florida 34684, United States

Pfizer Investigational Site, South Miami, Florida 33143, United States

Pfizer Investigational Site, Tampa, Florida 33614-7118, United States

Pfizer Investigational Site, Zephyrhills, Florida 33542, United States

Pfizer Investigational Site, Decatur, Georgia 30033, United States

Pfizer Investigational Site, Watford, Herts WD25 0EA, United Kingdom

Pfizer Investigational Site, Springfield, Illinois 62704, United States

Pfizer Investigational Site, Dubuque, Iowa 52001-7313, United States

Pfizer Investigational Site, Dubuque, Iowa 52002, United States

Pfizer Investigational Site, Canterbury, Kent CT1 3HX, United Kingdom

Pfizer Investigational Site, Lexington, Kentucky 40509, United States

Pfizer Investigational Site, Madisonville, Kentucky 42431, United States

Pfizer Investigational Site, Wigan, Lancs WN6 9EP, United Kingdom

Pfizer Investigational Site, Baltimore, Maryland 21218, United States

Pfizer Investigational Site, Clinton, Maryland 20735, United States

Pfizer Investigational Site, Frederick, Maryland 21702, United States

Pfizer Investigational Site, Greenbelt, Maryland 20770, United States

Pfizer Investigational Site, Wheaton, Maryland 20902, United States

Pfizer Investigational Site, Brockton, Massachusetts 02301, United States

Pfizer Investigational Site, Bradwell Common, Milton Keynes MK13 8RN, United Kingdom

Pfizer Investigational Site, Jefferson City, Missouri 65101, United States

Pfizer Investigational Site, Jefferson City, Missouri 65109, United States

Pfizer Investigational Site, Springfield, Missouri 65807, United States

Pfizer Investigational Site, Lincoln, Nebraska 68516, United States

Pfizer Investigational Site, Omaha, Nebraska 68134, United States

Pfizer Investigational Site, Las Vegas, Nevada 89106, United States

Pfizer Investigational Site, Las Vegas, Nevada 89144, United States

Pfizer Investigational Site, Great Neck, New York 11021, United States

Pfizer Investigational Site, Manlius, New York 13104, United States

Pfizer Investigational Site, Mineola, New York 11501, United States

Pfizer Investigational Site, New York, New York 10022-1009, United States

Pfizer Investigational Site, Rochester, New York 14609, United States

Pfizer Investigational Site, St. John's, Newfoundland and Labrador A1E 2C2, Canada

Pfizer Investigational Site, St. John's, Newfoundland and Labrador A1E 2E2, Canada

Pfizer Investigational Site, St. John's, Newfoundland and Labrador A1A 3R5, Canada

Pfizer Investigational Site, Winston Salem, North Carolina 27103-4019, United States

Pfizer Investigational Site, Winston-Salem, North Carolina 27103, United States

Pfizer Investigational Site, Greenisland, Carrickfergus, Northern Ireland BT38 8TP, United Kingdom

Pfizer Investigational Site, Cleveland, Ohio 44122, United States

Pfizer Investigational Site, Columbus, Ohio 43210-1228, United States

Pfizer Investigational Site, Zanesville, Ohio 43701, United States

Pfizer Investigational Site, Corunna, Ontario N0N 1G0, Canada

Pfizer Investigational Site, Hamilton, Ontario L8M 1K7, Canada

Pfizer Investigational Site, London, Ontario N6C 5J1, Canada

Pfizer Investigational Site, Newmarket, Ontario L3Y 5G8, Canada

Pfizer Investigational Site, North York, Ontario M3M 3E5, Canada

Pfizer Investigational Site, Sarnia, Ontario N7T 4X3, Canada

Pfizer Investigational Site, Toronto, Ontario M9W 4L6, Canada

Pfizer Investigational Site, Windsor, Ontario N8X 5A6, Canada

Pfizer Investigational Site, Eugene, Oregon 97401, United States

Pfizer Investigational Site, Beaver, Pennsylvania 15009, United States

Pfizer Investigational Site, Camp Hill, Pennsylvania 17011, United States

Pfizer Investigational Site, Duncansville, Pennsylvania 16635-0909, United States

Pfizer Investigational Site, Johnstown, Pennsylvania 15904, United States

Pfizer Investigational Site, Philadephia, Pennsylvania 19152, United States

Pfizer Investigational Site, Charlottetown, Prince Edward Island C1A 5Y9, Canada

Pfizer Investigational Site, Montague, Prince Edward Island C0A 1R0, Canada

Pfizer Investigational Site, Mirabel, Quebec J7J 2K8, 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, Ste-Foy, Quebec G1W 4R4, Canada

Pfizer Investigational Site, Santiago, RM, Chile

Pfizer Investigational Site, Porto Alegre, RS 90035-903, Brazil

Pfizer Investigational Site, Porto Alegre, RS 90610-000, Brazil

Pfizer Investigational Site, Campinas, SP 13073-350, Brazil

Pfizer Investigational Site, São Paulo, SP 04027-000, Brazil

Pfizer Investigational Site, Saskatoon, Saskatchewan S7K 0H6, Canada

Pfizer Investigational Site, Johnson City, Tennessee 37601, United States

Pfizer Investigational Site, Knoxville, Tennessee 37920, United States

Pfizer Investigational Site, New Tazewell, Tennessee 37825, United States

Pfizer Investigational Site, Dallas, Texas 75231, United States

Pfizer Investigational Site, Dallas, Texas 75235, United States

Pfizer Investigational Site, Viña Del Mar, V Region, Chile

Pfizer Investigational Site, Rancagua, VI Región, Chile

Pfizer Investigational Site, Barry, Vale of Glamorgan CF62 7EB, United Kingdom

Pfizer Investigational Site, Arlington, Virginia 22205, United States

Pfizer Investigational Site, Renton, Washington 98055, United States

Pfizer Investigational Site, Tacoma, Washington 98405, United States

Pfizer Investigational Site, Yakima, Washington 98902-4876, United States

Pfizer Investigational Site, Yakima, Washington 98902, United States

Pfizer Investigational Site, Pound Hill, Crawley, West Sussex RH10 7DX, United Kingdom

Pfizer Investigational Site, Bradford on Avon, Wiltshire BA15 1DQ, United Kingdom

Pfizer Investigational Site, Midsomer Norton, Wiltshire BA3 2UH, United Kingdom

Pfizer Investigational Site, Milwaukee, Wisconsin 53209, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: July 2005
Last updated: June 24, 2009

Page last updated: August 20, 2015

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