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

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NCT00139776

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Huntsville, Alabama, 35801 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.

NCT00139776
Pfizer
Completed
Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use"

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Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use"
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Osteoarthritis, Knee
  • Osteoarthritis, Hip
  • 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.
  • Active Comparator: Celecoxib - Continuous use
    Intervention: Drug: Celecoxib
  • Active Comparator: Celecoxib - Intermittent use
    Intervention: Drug: Celecoxib
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.
 
Completed
875
February 2008
February 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Brazil,   Canada,   Chile,   Colombia,   France,   United Kingdom,   United States
 
 
NCT00139776
A3191173
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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