Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00577473
First received: December 19, 2007
Last updated: September 14, 2011
Last verified: September 2011
Results First Received: May 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Ulcerative Colitis
Intervention: Drug: mesalamine

  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
Screening began 9 Feb 2001

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
Asacol 2.4 g/Day 2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
Asacol 4.8 g/Day 2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks

Participant Flow:   Overall Study
    Asacol 2.4 g/Day     Asacol 4.8 g/Day  
STARTED     154     147  
ITT Population     150     136  
COMPLETED     133     123  
NOT COMPLETED     21     24  
Protocol Violation                 1                 4  
Adverse Event                 8                 5  
Withdrawal by Subject                 2                 6  
Physician Decision                 2                 2  
Lack of Efficacy                 8                 7  



  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
Asacol 2.4 g/Day 2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
Asacol 4.8 g/Day 2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Total Total of all reporting groups

Baseline Measures
    Asacol 2.4 g/Day     Asacol 4.8 g/Day     Total  
Number of Participants  
[units: participants]
  154     147     301  
Age, Customized  
[units: Participants]
     
18 - 64 years     141     133     274  
>= 65 years     13     14     27  
Gender  
[units: participants]
     
Female     79     67     146  
Male     75     80     155  
Race/Ethnicity, Customized  
[units: Partcipants]
     
Caucasian     122     116     238  
Black or African American     18     18     36  
Asian (Indian)     2     2     4  
Asian (Oriental)     1     0     1  
Hispanic     10     9     19  
Multi-racial/other     1     2     3  



  Outcome Measures
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1.  Primary:   Percentage of Patients Classified as Treatment Success at Week 6, ITT Population   [ Time Frame: 6 weeks ]

2.  Secondary:   Percentage of Patients Classified as Treatment Success at Week 3, ITT Population   [ Time Frame: 3 weeks ]

3.  Secondary:   Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients   [ Time Frame: Week 3 ]

4.  Secondary:   Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients   [ Time Frame: Week 6 ]

5.  Secondary:   Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage)   [ Time Frame: Week 3 ]

6.  Secondary:   Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage)   [ Time Frame: Week 6 ]

7.  Secondary:   Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage)   [ Time Frame: Week 3 ]

8.  Secondary:   Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage)   [ Time Frame: Week 6 ]

9.  Secondary:   Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage)   [ Time Frame: Week 3 ]

10.  Secondary:   Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage)   [ Time Frame: Week 6 ]

11.  Secondary:   Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage)   [ Time Frame: Week 3 ]

12.  Secondary:   Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage)   [ Time Frame: Week 6 ]


  Serious Adverse Events


  Other Adverse Events


  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: NCT00577473     History of Changes
Other Study ID Numbers: 2000083
Study First Received: December 19, 2007
Results First Received: May 24, 2011
Last Updated: September 14, 2011
Health Authority: United States: Food and Drug Administration