Canadian Active & Maintenance Modified Pentasa Study (CAMMP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00603733
First received: January 16, 2008
Last updated: April 21, 2016
Last verified: April 2016
Results First Received: March 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Active Ulcerative Colitis
Remission of Ulcerative Colitis
Intervention: Drug: 5-ASA (5-Aminosalicylate)

  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

Total number of unique patients enrolled in the study is 288 whereby 190 patients were enrolled in the Active Phase and 98 patients were enrolled in the Run-In Phase.

The patients enrolled in the Maintenance Phase are a combination of patients who completed the Active (82) and Run In (71) Phases and were eligible to move forward into Maintenance.


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
Pentasa® Modified Extended Release

5-ASA (5-Aminosalicylate)

5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)

Pentasa®

5-ASA (5-Aminosalicylate)

5-ASA (5-Aminosalicylate): 500 mg tablet


Participant Flow for 3 periods

Period 1:   Active Phase ITT
    Pentasa® Modified Extended Release     Pentasa®  
STARTED     95 [1]   95  
COMPLETED     84     78  
NOT COMPLETED     11     17  
Adverse Event                 8                 7  
Withdrawal by Subject                 0                 3  
Lost to Follow-up                 0                 1  
Did not meet inclusion/exclusion                 1                 3  
Lack of Efficacy                 1                 2  
Subject moved, site closed                 1                 1  
[1] Note: a total of 190 new participants were enrolled and randomized in the Active Phase

Period 2:   Run-In Phase - 4 Weeks
    Pentasa® Modified Extended Release     Pentasa®  
STARTED     49 [1]   49  
COMPLETED     35     36  
NOT COMPLETED     14     13  
Adverse Event                 2                 1  
Withdrawal by Subject                 4                 1  
Lost to Follow-up                 1                 0  
Did not meet incl/excl criteria                 5                 10  
Lack of Efficacy                 2                 1  
[1] Note: Of the 98 subjects randomized at Run-In, 71 progressed into the maintenance phase.

Period 3:   Maintenance Phase ITT
    Pentasa® Modified Extended Release     Pentasa®  
STARTED     71 [1]   82  
COMPLETED     61     66  
NOT COMPLETED     10     16  
Adverse Event                 3                 6  
Withdrawal by Subject                 1                 0  
Protocol Violation                 1                 1  
Lost to Follow-up                 0                 1  
Lack of Efficacy                 2                 2  
Physician Decision                 0                 1  
Site withdrew, subject away, lost IMP                 3                 5  
[1] Note:82 subjects randomized at Active phase & 71 at Run-In phase progressed to the maintenance phase



  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.
Baseline characteristics were reported for the Per Protocol population who participated in the Active phase and in the maintenance phase of this study.

Reporting Groups
  Description
Pentasa® Modified Extended Release

5-ASA (5-Aminosalicylate)

5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)

Pentasa®

5-ASA (5-Aminosalicylate)

5-ASA (5-Aminosalicylate): 500 mg tablet

Total Total of all reporting groups

Baseline Measures
    Pentasa® Modified Extended Release     Pentasa®     Total  
Number of Participants  
[units: participants]
  139     146     285  
Age  
[units: years]
Mean (Standard Deviation)
     
Active Phase     44.2  (12.88)     44.5  (12.53)     44.35  (12.71)  
Maintenance Phase     46.4  (12.20)     45.8  (13.45)     46.1  (12.83)  
Age, Customized  
[units: years]
Median (Full Range)
     
Active Phase     45  
  (18 to 68)  
  43.5  
  (22 to 76)  
  44.3  
  (18 to 76)  
Maintenance Phase     48  
  (20 to 65)  
  44.5  
  (23 to 76)  
  46.3  
  (20 to 76)  
Gender, Customized  
[units: participants]
     
Active Phase, Female     30     34     64  
Active Phase, Male     48     44     92  
Maintenance Phase, Female     28     29     57  
Maintenance Phase, Male     33     39     72  
Region of Enrollment  
[units: participants]
     
Canada     139     146     285  



  Outcome Measures
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1.  Primary:   Active Phase: Proportion of Active Subjects Achieving Overall Improvement   [ Time Frame: From baseline to week 8 ]

2.  Primary:   Maintenance Phase: Proportion of Subjects Experiencing Relapse   [ Time Frame: Up to week 24 ]

3.  Secondary:   Frequency of Adverse Events   [ Time Frame: From baseline to week 24 ]


  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
Study was amended to modify sample size as subject enrolment was lower than anticipated. A data lock was imposed, pending completion of the Maintenance Phase by 12 subjects to report all Active Phase efficacy data & all available safety data.


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
e-mail: DK0-Disclosure@ferring.com



Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00603733     History of Changes
Other Study ID Numbers: CLN 35.3.11
Study First Received: January 16, 2008
Results First Received: March 4, 2015
Last Updated: April 21, 2016
Health Authority: Canada: Health Canada