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A Comparison of Once a Day Dose Compared to 2 Doses/Day

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00505778
First received: July 20, 2007
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
Results First Received: April 18, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Ulcerative Colitis
Interventions: Drug: Mesalamine Once-Daily
Drug: Mesalamine Twice-Daily

  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
Enrollment began 9 Aug 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Mesalamine Once-Daily an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
Mesalamine Twice-Daily an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)

Participant Flow:   Overall Study
    Mesalamine Once-Daily     Mesalamine Twice-Daily  
STARTED     514     513  
Intent to Treat (ITT) Population     512     511  
COMPLETED     380     378  
NOT COMPLETED     134     135  
Adverse Event                 2                 7  
Physician Decision                 8                 14  
Lost to Follow-up                 17                 23  
Unable to Meet Protocol Criteria                 4                 1  
Protocol Violation                 7                 9  
Withdrawal by Subject                 29                 14  
Relapse                 65                 65  
Took No Study Drug                 2                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Mesalamine Once-Daily an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
Mesalamine Twice-Daily an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
Total Total of all reporting groups

Baseline Measures
    Mesalamine Once-Daily     Mesalamine Twice-Daily     Total  
Number of Participants  
[units: participants]
 		  514     513     1027  
Age, Customized [1]
[units: Participants]
 		     
< 65 years old     409     414     823  
> = 65 years old     103     97     200  
Gender [1]
[units: participants]
 		     
Female     261     268     529  
Male     251     243     494  
Region of Enrollment [1]
[units: participants]
 		     
Canada     6     8     14  
United States     506     503     1009  
[1] ITT Population



  Outcome Measures
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1.  Primary:   Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI)   [ Time Frame: 6 months ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Patients Remaining in Remission at Month 3, ITT Population   [ Time Frame: 3 months ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Patients Remaining in Remission at Month 12, ITT Population   [ Time Frame: 12 months ]
  Show Outcome Measure 3

4.  Secondary:   Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population   [ Time Frame: 6 months ]
  Show Outcome Measure 4

5.  Secondary:   Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6   [ Time Frame: 6 months ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6   [ Time Frame: 6 months ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Grexan Wulff, Manager Regulatory Affairs
Organization: Warner Chilcott
phone: 973-442-3376
e-mail: gwulff@wcrx.com


No publications provided by Warner Chilcott

Publications automatically indexed to this study:


Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00505778     History of Changes
Other Study ID Numbers: 2007021
Study First Received: July 20, 2007
Results First Received: April 18, 2011
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration