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Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tillotts Pharma AG
ClinicalTrials.gov Identifier:
NCT01059344
First received: January 28, 2010
Last updated: May 29, 2017
Last verified: May 2017
Results First Received: October 24, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Ulcerative Colitis
Intervention: Drug: Mesalamin

  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
November 2009 - February 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screen failures, not complying to inclusion and exclusion criteria

Reporting Groups
  Description
Mesalamin Mesalamin: 4.8g/day, 800 mg tablets
Placebo Placebo to Mesalamin: 4.8g/day, 800 mg tablets

Participant Flow:   Overall Study
    Mesalamin   Placebo
STARTED   140   141 
COMPLETED   118   95 
NOT COMPLETED   22   46 
Adverse Event                12                30 
Withdrawal by Subject                6                9 
Lost to Follow-up                1                1 
Other                3                6 



  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
Mesalamin Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
Placebo Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
Total Total of all reporting groups

Baseline Measures
   Mesalamin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 140   141   281 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.6  (14.3)   40.72  (13.8)   41.8  (14.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      53  37.9%      66  46.8%      119  42.3% 
Male      87  62.1%      75  53.2%      162  57.7% 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   114   110   224 
Asian   26   31   57 
Region of Enrollment 
[Units: Participants]
     
Turkey   13   11   24 
Ukraine   54   55   109 
Belarus   47   44   91 
India   26   31   57 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC).   [ Time Frame: 6 weeks ]

2.  Secondary:   Clinical Remission   [ Time Frame: 10 weeks ]

3.  Secondary:   Endoscopic Remission   [ Time Frame: 6 weeks ]

4.  Secondary:   Endoscopic Remission   [ Time Frame: 10 weeks ]

5.  Secondary:   Improvement   [ Time Frame: 6 weeks ]

6.  Secondary:   Improvement   [ Time Frame: 10 weeks ]

7.  Post-Hoc:   To Achieve Clinical Remission in the Patient Population Confirmed by the Central Reader   [ Time Frame: 6 weeks ]


  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
Investigator endoscopy scores resultet in 31% patients with insuficient disease severity at baseline. Central reader scores were used for a post hoc analysis of the primary endpoint, including patients with pre-specified disease severity only.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Brian G. Feagan et al
Organization: The Role of Centralized Reading of Endoscopy in a Randomized Controlled Trial of Mesalamine for Ulcertive Colitis
phone: Gastroenterology 2013; 145: ext 149-157


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

Responsible Party: Tillotts Pharma AG
ClinicalTrials.gov Identifier: NCT01059344     History of Changes
Other Study ID Numbers: TP0203
Study First Received: January 28, 2010
Results First Received: October 24, 2016
Last Updated: May 29, 2017