Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00713310
First received: July 9, 2008
Last updated: April 3, 2012
Last verified: April 2012
Results First Received: March 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Ulcerative Colitis
Intervention: Drug: Asacol 400 mg

  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
Recruitment began 16 Dec 2008

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
Low-Dose 17-<33kg: AM - 2 Asacol 400mg & 1 placebo, PM - 1 Asacol 400mg & 1 placebo; 33-<54kg: AM - 3 Asacol 400mg & 2 placebo, PM - 2 Asacol 400mg & 2 placebo; 54-<90kg: AM & PM - 3 Asacol 400mg & 3 placebo
High-Dose 17-<33kg: AM 3 Asacol 400mg, PM 2 Asacol 400mg; 33-<54kg: AM5 Asacol 400mg, PM 4 Asacol 400mg; 54-<90kg: AM & PM 6 Asacol 400mg

Participant Flow:   Overall Study
    Low-Dose     High-Dose  
STARTED     41     42  
mITT Population     41     41 [1]
COMPLETED     36     36  
NOT COMPLETED     5     6  
Adverse Event                 5                 2  
Lack of Efficacy                 0                 2  
Withdrawal by Subject                 0                 2  
[1] 1 subject randomized to high dose not dosed so not included in the mITT population.



  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
Low-Dose 17-<33kg: AM - 2 Asacol 400mg & 1 placebo, PM - 1 Asacol 400mg & 1 placebo; 33-<54kg: AM - 3 Asacol 400mg & 2 placebo, PM - 2 Asacol 400mg & 2 placebo; 54-<90kg: AM & PM - 3 Asacol 400mg & 3 placebo
High-Dose 17-<33kg: AM 3 Asacol 400mg, PM 2 Asacol 400mg; 33-<54kg: AM5 Asacol 400mg, PM 4 Asacol 400mg; 54-<90kg: AM & PM 6 Asacol 400mg
Total Total of all reporting groups

Baseline Measures
    Low-Dose     High-Dose     Total  
Number of Participants  
[units: participants]
  41     42     83  
Age [1]
[units: years]
Mean ± Standard Deviation
  13.0  ± 3.2     12.8  ± 3.0     12.9  ± 3.1  
Age, Customized  
[units: participants]
     
5-8 years     4     4     8  
9-17 years     37     38     75  
Gender  
[units: participants]
     
Female     22     23     45  
Male     19     19     38  
Region of Enrollment  
[units: participants]
     
United States     26     23     49  
Canada     0     4     4  
Poland     9     10     19  
Romania     2     3     5  
Croatia     4     2     6  
[1] mITT Population



  Outcome Measures
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1.  Primary:   Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population   [ Time Frame: Baseline and 6 weeks ]

2.  Secondary:   Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT   [ Time Frame: Baseline and Week 6 ]


  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


No publications provided


Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00713310     History of Changes
Other Study ID Numbers: 2007017
Study First Received: July 9, 2008
Results First Received: March 6, 2012
Last Updated: April 3, 2012
Health Authority: United States: Food and Drug Administration