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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00139776
First received: August 29, 2005
Last updated: June 24, 2009
Last verified: June 2009
History of Changes

August 29, 2005
June 24, 2009
July 2005
February 2008   (final data collection date for primary outcome measure)
Number of Flare Events Per Time of Exposure to Study Medication [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
To determine whether continuous use over a 6-month period of celecoxib 200 mg per day is more effective than intermittent use of celecoxib 200 mg per day in preventing spontaneous osteoarthritis flares.
Complete list of historical versions of study NCT00139776 on ClinicalTrials.gov Archive Site
  • Time to Occurrence of First Osteoarthritis (OA) Flare [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
  • Proportion of Days Free From Osteoarthritis (OA) Flare [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
  • Proportion of Days in Osteoarthritis (OA) Flare [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
  • Arthritis Pain Numerical Rating Scale (NRS) [ Time Frame: Period III ] [ Designated as safety issue: No ]
  • Patient's Global Assessment of Arthritis [ Time Frame: Period III ] [ Designated as safety issue: No ]
  • Physician's Global Assessment of Arthritis at Final Visit [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
  • Total Rescue Medication Taken (Mean) [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
  • Proportion of Days on Rescue Medication [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
  • Days on Flare Medication [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
  • Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
  • Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
To evaluate the safety and tolerability of continuous use over a 6-month period of celecoxib 200 mg QD versus "usual use" celecoxib 200mg QD. To assess whether disease management
Not Provided
Not Provided
 
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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. 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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Brazil,   Canada,   Chile,   Colombia,   France,   United Kingdom
 
NCT00139776
A3191173
Yes
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