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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
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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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.
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)
Total Total of all reporting groups

Baseline Measures
   Mesalamine Once-Daily   Mesalamine Twice-Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 514   513   1027 
Age, Customized [1] 
[Units: Participants]
     
< 65 years old   409   414   823 
> = 65 years old   103   97   200 
[1] ITT Population
Gender [1] 
[Units: Participants]
     
Female   261   268   529 
Male   251   243   494 
[1] ITT Population
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 ]

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

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

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

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

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


  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 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.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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