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

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NCT00139776

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Study Location
Pfizer Investigational Site
Huntsville, Alabama, 35801, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Knee Osteoarthritis, Hip Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subject has had surgery on index joint.


- Subject has history of rheumatoid arthritis or fibromyalgia syndrome.


- Subject has active gastrointestinal or cardiovascular disease.

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Knee Osteoarthritis, Hip OsteoarthritisStudy Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use"
NCT00139776
  1. Huntsville, Alabama
  2. Peoria, Arizona
  3. Phoenix, Arizona
  4. Anaheim, California
  5. Huntington Beach, California
  6. Long Beach, California
  7. Orange, California
  8. Paramount, California
  9. Stockton, California
  10. Tustin, California
  11. Walnut Creek, California
  12. Whittier, California
  13. Wheatridge, Colorado
  14. Danbury, Connecticut
  15. New Milford, Connecticut
  16. Waterbury, Connecticut
  17. Ocala, Florida
  18. Palm Harbor, Florida
  19. South Miami, Florida
  20. Tampa, Florida
  21. Zephyrhills, Florida
  22. Decatur, Georgia
  23. Springfield, Illinois
  24. Dubuque, Iowa
  25. Dubuque, Iowa
  26. Lexington, Kentucky
  27. Madisonville, Kentucky
  28. Baltimore, Maryland
  29. Clinton, Maryland
  30. Frederick, Maryland
  31. Greenbelt, Maryland
  32. Wheaton, Maryland
  33. Brockton, Massachusetts
  34. Jefferson City, Missouri
  35. Jefferson City, Missouri
  36. Springfield, Missouri
  37. Lincoln, Nebraska
  38. Omaha, Nebraska
  39. Las Vegas, Nevada
  40. Las Vegas, Nevada
  41. Great Neck, New York
  42. Manlius, New York
  43. Mineola, New York
  44. New York, New York
  45. Rochester, New York
  46. Winston Salem, North Carolina
  47. Winston-Salem, North Carolina
  48. Cleveland, Ohio
  49. Columbus, Ohio
  50. Zanesville, Ohio
  51. Eugene, Oregon
  52. Beaver, Pennsylvania
  53. Camp Hill, Pennsylvania
  54. Duncansville, Pennsylvania
  55. Johnstown, Pennsylvania
  56. Philadephia, Pennsylvania
  57. Johnson City, Tennessee
  58. Knoxville, Tennessee
  59. New Tazewell, Tennessee
  60. Dallas, Texas
  61. Dallas, Texas
  62. Arlington, Virginia
  63. Renton, Washington
  64. Tacoma, Washington
  65. Yakima, Washington
  66. Yakima, Washington
  67. Milwaukee, Wisconsin
  68. Ham,
  69. Liege,
  70. Porto Alegre, RS
  71. Porto Alegre, RS
  72. Campinas, SP
  73. São Paulo, SP
  74. Calgary, Alberta
  75. Vancouver, British Columbia
  76. St. John's, Newfoundland and Labrador
  77. St. John's, Newfoundland and Labrador
  78. St. John's, Newfoundland and Labrador
  79. Corunna, Ontario
  80. Hamilton, Ontario
  81. London, Ontario
  82. Newmarket, Ontario
  83. North York, Ontario
  84. Sarnia, Ontario
  85. Toronto, Ontario
  86. Windsor, Ontario
  87. Charlottetown, Prince Edward Island
  88. Montague, Prince Edward Island
  89. Mirabel, Quebec
  90. Montreal, Quebec
  91. Rimouski, Quebec
  92. Sherbrooke, Quebec
  93. Ste-Foy, Quebec
  94. Saskatoon, Saskatchewan
  95. Santiago, RM
  96. Viña Del Mar, V Region
  97. Rancagua, VI Región
  98. Bogota, Cundinamarca
  99. Barranquila,
  100. Bogota,
  101. Bucaramanga,
  102. Joue Les Tours,
  103. L'Union,
  104. Poitiers,
  105. Tours,
  106. Randalstown, Co Antrim
  107. Newtownabbey, Co.Antrim
  108. Leslie, Fife
  109. Watford, Herts
  110. Canterbury, Kent
  111. Wigan, Lancs
  112. Bradwell Common, Milton Keynes
  113. Greenisland, Carrickfergus, Northern Ireland
  114. Barry, Vale of Glamorgan
  115. Pound Hill, Crawley, West Sussex
  116. Bradford on Avon, Wiltshire
  117. Midsomer Norton, Wiltshire
  118. Bangor,
  119. Bath,
  120. Belfast,
  121. Blackpool,
  122. Cardiff,
  123. Cookstown,
  124. Trowbridge,
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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use"
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis, Knee
  • Osteoarthritis, Hip
Intervention  ICMJE
  • 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.

  • 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.

Study Arms  ICMJE
  • Active Comparator: Celecoxib - Continuous use
    Intervention: Drug: Celecoxib
  • Active Comparator: Celecoxib - Intermittent use
    Intervention: Drug: Celecoxib
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2008)		875
Original Enrollment  ICMJE
 (submitted: August 30, 2005)		812
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Brazil,   Canada,   Chile,   Colombia,   France,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00139776
Other Study ID Numbers  ICMJE A3191173
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP