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

NCT00139776 | Completed Phase 4 Results DMC

• 1 other identifier: A3191173
• Study Type: interventional
• Target: 875
• Locations: 8 countries
• Sites: 124

Brief 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.

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Keywords

Chronic treatment osteoarthritis, Celecoxib, Continuous Use, Intermittent Use

Outcome Measures

Primary Outcomes (1)

• Number of Flare Events Per Time of Exposure to Study Medication

  Number of flare events per month during Period III (calculated as number of flares divided by number of months participant was enrolled during Period III). Flare was determined using pre-defined criteria, using an interactive voice response system.

  Period III (22 weeks)

Secondary Outcomes (11)

• Time to Occurrence of First Osteoarthritis (OA) Flare

  Period III (22 weeks)

• Proportion of Days Free From Osteoarthritis (OA) Flare

  Period III (22 weeks)

• Proportion of Days in Osteoarthritis (OA) Flare

  Period III (22 weeks)

• Arthritis Pain Numerical Rating Scale (NRS)

  Period III

• Patient's Global Assessment of Arthritis

  Period III

Other Outcomes (4)

• Change in Medical Outcomes Study Sleep Scale - All Assessments

  Period III

• Medical Outcomes Study Sleep Scale - Number of Participants With Optimal, Mixed and Not Optimal Sleep

  Period III

• Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments

  Period III

Study Arms (2)

Celecoxib - Continuous use

ACTIVE COMPARATOR

Drug: Celecoxib

Celecoxib - Intermittent use

ACTIVE COMPARATOR

Drug: Celecoxib

Interventions

Celecoxib DRUG

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 - Continuous use

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subject has had surgery on index joint.
• Subject has history of rheumatoid arthritis or fibromyalgia syndrome.
• Subject has active gastrointestinal or cardiovascular disease.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (124)

Pfizer Investigational Site

Huntsville, Alabama, 35801, United States

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Peoria, Arizona, 85381, United States

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Phoenix, Arizona, 85051, United States

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Anaheim, California, 92801, United States

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Huntington Beach, California, 92646, United States

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Long Beach, California, 90806, United States

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Orange, California, 92868, United States

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Paramount, California, 90723, United States

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Stockton, California, 95204, United States

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Tustin, California, 92780, United States

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Walnut Creek, California, 94598, United States

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Whittier, California, 90601, United States

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Wheat Ridge, Colorado, 80033, United States

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Danbury, Connecticut, 06810, United States

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New Milford, Connecticut, 06776, United States

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Waterbury, Connecticut, 06708, United States

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Ocala, Florida, 34474, United States

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Palm Harbor, Florida, 34684, United States

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South Miami, Florida, 33143, United States

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Tampa, Florida, 33614-7118, United States

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Zephyrhills, Florida, 33542, 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

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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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Frederick, Maryland, 21702, United States

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Greenbelt, Maryland, 20770, 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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Lincoln, Nebraska, 68516, United States

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Omaha, Nebraska, 68134, 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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Great Neck, New York, 11021, United States

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Manlius, New York, 13104, United States

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Mineola, New York, 11501, United States

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New York, New York, 10022-1009, United States

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Rochester, New York, 14609, 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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Columbus, Ohio, 43210-1228, United States

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Zanesville, Ohio, 43701, United States

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Eugene, Oregon, 97401, United States

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Beaver, Pennsylvania, 15009, United States

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Camp Hill, Pennsylvania, 17011, 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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Philadelphia, Pennsylvania, 19152, United States

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Johnson City, Tennessee, 37601, United States

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Knoxville, Tennessee, 37920, United States

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New Tazewell, Tennessee, 37825, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75235, United States

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Arlington, Virginia, 22205, United States

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Renton, Washington, 98055, United States

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Tacoma, Washington, 98405, United States

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Yakima, Washington, 98902-4876, United States

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Yakima, Washington, 98902, United States

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Milwaukee, Wisconsin, 53209, United States

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Ham, 3945, Belgium

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Liège, 4000, Belgium

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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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Campinas, São Paulo, 13073-350, Brazil

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São Paulo, São Paulo, 04027-000, Brazil

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Calgary, Alberta, T2S 2S7, Canada

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Vancouver, British Columbia, V5K 1K3, Canada

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

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

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

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Corunna, Ontario, N0N 1G0, Canada

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Hamilton, Ontario, L8M 1K7, Canada

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London, Ontario, N6C 5J1, Canada

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Newmarket, Ontario, L3Y 5G8, Canada

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North York, Ontario, M3M 3E5, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Windsor, Ontario, N8X 5A6, Canada

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Charlottetown, Prince Edward Island, C1A 5Y9, Canada

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Montague, Prince Edward Island, C0A 1R0, Canada

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Mirabel, Quebec, J7J 2K8, Canada

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Montreal, Quebec, H4N 2W2, Canada

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Rimouski, Quebec, G5L 9A8, Canada

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Sherbrooke, Quebec, J1H 1Z1, Canada

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Ste-Foy, Quebec, G1W 4R4, Canada

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Saskatoon, Saskatchewan, S7K 0H6, Canada

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Viña del Mar, Región de Valparaíso, Chile

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Rancagua, Región del Libertador General Bernardo O’Higgins, Chile

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Santiago, RM, Chile

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Bogota, Cundinamarca, Colombia

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Barranquila, Colombia

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Bogotá, Colombia

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Bucaramanga, Colombia

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Joué-lès-Tours, 37300, France

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L'Union, 31240, France

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Poitiers, 86000, France

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Tours, 37000, France

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Randalstown, Co Antrim, BT41 3AE, United Kingdom

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Newtownabbey, Co.Antrim, BT37 9QN, United Kingdom

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Leslie, Fife, KY6 3LQ, United Kingdom

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Watford, Herts, WD25 0EA, United Kingdom

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Canterbury, Kent, CT1 3HX, United Kingdom

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Wigan, Lancs, WN6 9EP, United Kingdom

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Bradwell Common, Milton Keynes, MK13 8RN, United Kingdom

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Greenisland, Carrickfergus, Northern Ireland, BT38 8TP, United Kingdom

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Barry, Vale Of Glamorgan, CF62 7EB, United Kingdom

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Pound Hill, Crawley, West Sussex, RH10 7DX, United Kingdom

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Bradford-on-Avon, Wiltshire, BA15 1DQ, United Kingdom

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Midsomer Norton, Wiltshire, BA3 2UH, United Kingdom

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Bangor, BT19 1PP, United Kingdom

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Bath, BA2 4BY, United Kingdom

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Belfast, BT14 6AR, United Kingdom

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Blackpool, FY4 3AD, United Kingdom

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Cardiff, CF24 2HP, United Kingdom

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Cookstown, BT80 8BG, United Kingdom

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Trowbridge, BA14 9AR, United Kingdom

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Related Publications (1)

• Strand V, Simon LS, Dougados M, Sands GH, Bhadra P, Breazna A, Immitt J. Treatment of osteoarthritis with continuous versus intermittent celecoxib. J Rheumatol. 2011 Dec;38(12):2625-34. doi: 10.3899/jrheum.110636. Epub 2011 Nov 1.

  PMID: 22045833 DERIVED

Related Links

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

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: August 31, 2005
• Study Start: July 1, 2005
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: March 29, 2021
• Results First Posted: May 19, 2009

Record last verified: 2021-03

Locations

US (67); GB (19); CL (3); CO (4); CA (21); BR (4); BE (2); FR (4)