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

Contact

[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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Pfizer Clinical Trials Contact Center

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NCT00139776
  1. Huntsville, Alabama
  2. Peoria, Arizona
  3. Phoenix, Arizona
  4. Anaheim, California
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  18. Palm Harbor, Florida
  19. South Miami, Florida
  20. Tampa, Florida
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  22. Decatur, Georgia
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  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
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  35. Jefferson City, Missouri
  36. Springfield, Missouri
  37. Lincoln, Nebraska
  38. Omaha, Nebraska
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  44. Freehold, New Jersey
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  46. Hartsdale, New York
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  51. Oklahoma City, Oklahoma
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  55. Rapid City, South Dakota
  56. Nashville, Tennessee
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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