Trial Summary
What is the purpose of this trial?The purpose of this study is to assess whether withdrawal of aminosalicylate (5-ASA) is non-inferior to continuation of 5-ASA therapy in Crohn's disease (CD) subjects in remission.
Eligibility Criteria
This trial is for individuals with Crohn's Disease who are currently in remission. Participants must have been taking an oral aminosalicylate (5-ASA) for at least 6 months, be compliant with their medication, and able to fully engage in the study. People with active fistulizing disease, recent flares or surgeries, other interventional trials within 3 months, or substance abuse issues cannot join.Inclusion Criteria
Subject-confirmed compliance with current aminosalicylate therapy (taking at least 75% of prescribed doses)
I was diagnosed with Crohn's disease over 3 months ago.
I have been taking an oral aminosalicylate medication for at least 6 months.
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Exclusion Criteria
I have untreated bile salt issues that might affect the study's tests.
Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study
History of active alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures
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Participant Groups
The study aims to determine if stopping aminosalicylate therapy (5-ASA withdrawal) is just as effective as continuing it for those in remission from Crohn's Disease. It compares two groups: one stops taking the drug while the other continues its use.
2Treatment groups
Experimental Treatment
Active Control
Group I: 5-ASA WithdrawalExperimental Treatment1 Intervention
Half of the subjects will discontinue their aminosalicylate therapy
Group II: 5-ASA ContinuationActive Control1 Intervention
Half of the subjects will continue on aminosalicylate therapy using the same dose and brand for the duration of the study
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Manitoba - Health Sciences CentreWinnipeg, Canada
Dr. O. Tarabain Medicine Professional CorporationWindsor, Canada
Taunton Surgical CenterOshawa, Canada
McGill University HealthcareMontréal, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Alimentiv Inc.Lead Sponsor
Academic Medical Organization of Southwestern OntarioCollaborator