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
Results First Received: February 20, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Intervention: Drug: Celecoxib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
111 centers in the Americas and Europe enrolled and treated subjects (2 centers in Belgium, 4 centers in Brazil, 20 centers in Canada, 5 centers in Chile, 5 centers in Columbia, 1 center in France, 15 centers in the United Kingdom, and 59 centers in the United States).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
17 participants completed Open-label run-in Period II and were randomized to Period III Double Blind but not treated.

Reporting Groups
  Description
Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories Period I (14+/-2 days) wash out and discontinuation of non-steroidal anti-inflammatories (NSAIDs) leading to osteoarthritis (OA) flare.
Open-Label Celecoxib Run-in Period Period II (14+/-2 days) run-in treatment with open label celecoxib to observe successful treatment of flare. Participants successfully treated randomized to 2 treatment groups in Period III (overall study).
Celecoxib 200mg Continuous Use Period III Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use Period III Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Participant Flow for 3 periods

Period 1:   Period I
    Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories     Open-Label Celecoxib Run-in Period     Celecoxib 200mg Continuous Use     Celecoxib 200mg Intermittent Use  
STARTED     1772     0     0     0  
COMPLETED     1197     0     0     0  
NOT COMPLETED     575     0     0     0  
Did not enter Period II                 575                 0                 0                 0  

Period 2:   Period II
    Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories     Open-Label Celecoxib Run-in Period     Celecoxib 200mg Continuous Use     Celecoxib 200mg Intermittent Use  
STARTED     0     1197     0     0  
COMPLETED     0     875     0     0  
NOT COMPLETED     0     322     0     0  
Not Randomized into Period III                 0                 322                 0                 0  

Period 3:   Period III
    Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories     Open-Label Celecoxib Run-in Period     Celecoxib 200mg Continuous Use     Celecoxib 200mg Intermittent Use  
STARTED     0     0     431 [1]   427 [2]
COMPLETED     0     0     355     321  
NOT COMPLETED     0     0     76     106  
Adverse Event                 0                 0                 22                 23  
Unknown                 0                 0                 23                 34  
Lack of Efficacy                 0                 0                 10                 24  
Lost to Follow-up                 0                 0                 5                 4  
Withdrawal by Subject                 0                 0                 16                 21  
[1] Randomized 440: 9 participants not treated
[2] Randomized 435: 8 participants not treated



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Celecoxib 200mg Continuous Use Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
Total Total of all reporting groups

Baseline Measures
    Celecoxib 200mg Continuous Use     Celecoxib 200mg Intermittent Use     Total  
Number of Participants  
[units: participants]
  431     427     858  
Age  
[units: years]
Mean ± Standard Deviation
  58.5  ± 10.00     58.7  ± 9.6     58.6  ± 9.8  
Gender  
[units: participants]
     
Female     317     303     620  
Male     114     124     238  



  Outcome Measures
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1.  Primary:   Number of Flare Events Per Time of Exposure to Study Medication   [ Time Frame: Period III (22 weeks) ]

2.  Secondary:   Time to Occurrence of First Osteoarthritis (OA) Flare   [ Time Frame: Period III (22 weeks) ]

3.  Secondary:   Proportion of Days Free From Osteoarthritis (OA) Flare   [ Time Frame: Period III (22 weeks) ]

4.  Secondary:   Proportion of Days in Osteoarthritis (OA) Flare   [ Time Frame: Period III (22 weeks) ]

5.  Secondary:   Arthritis Pain Numerical Rating Scale (NRS)   [ Time Frame: Period III ]

6.  Secondary:   Patient's Global Assessment of Arthritis   [ Time Frame: Period III ]

7.  Secondary:   Physician's Global Assessment of Arthritis at Final Visit   [ Time Frame: Period III (22 weeks) ]

8.  Secondary:   Total Rescue Medication Taken (Mean)   [ Time Frame: Period III (22 weeks) ]

9.  Secondary:   Proportion of Days on Rescue Medication   [ Time Frame: Period III (22 weeks) ]

10.  Secondary:   Days on Flare Medication   [ Time Frame: Period III (22 weeks) ]

11.  Secondary:   Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores   [ Time Frame: Period III (22 weeks) ]

12.  Secondary:   Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores   [ Time Frame: Period III (22 weeks) ]

13.  Other Pre-specified:   Change in Medical Outcomes Study Sleep Scale - All Assessments   [ Time Frame: Period III ]

14.  Other Pre-specified:   Medical Outcomes Study Sleep Scale - Number of Participants With Optimal, Mixed and Not Optimal Sleep   [ Time Frame: Period III ]

15.  Other Pre-specified:   Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments   [ Time Frame: Period III ]

16.  Other Pre-specified:   Serious Adverse Events in Open Label run-in Period   [ Time Frame: 2 weeks prior to double blind dosing ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00139776     History of Changes
Other Study ID Numbers: A3191173
Study First Received: August 29, 2005
Results First Received: February 20, 2009
Last Updated: June 24, 2009
Health Authority: United States: Food and Drug Administration