Status and phase
Conditions
Treatments
About
Several oral mesalazine (5-ASA) formulations exist, but the regimes require several tablets per day. Such regimens are not ideal and can interfere with normal daily activities of patients. Non-adherence has been associated with an increase in the risk of relapse and worse disease course; leading to a decrease in quality of life, an increase in societal and personal costs, and worst case increases the risk of colorectal cancer. Recently, a new formula for 5-ASA has been approved by the Danish Medicine Agency, with a single tablet regime per day.
Primary purpose:
• To investigate whether a simplified treatment regimen for 5- ASA (1600 mg as one tablet per day [intervention]) improves adherence with preserved remission rates compared to conventional therapy.
Secondary purposes:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Signed informed consent
Age between and including 18 and 60
Diagnosed with UC according to the Copenhagen Diagnostic Criteria
Length of disease of max. 10 years
Stable remission on 5-ASA (defined as partial Mayo score ≤1) for at least 2 months without need for oral corticosteroids before inclusion.
Endoscopic remission defined as Mayo Clinic Endoscopic Score < 2
Have had a relapse within the last 2 years
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
200 participants in 2 patient groups
Loading...
Central trial contact
Flemming Bendtsen, MDSci; Bobby Lo, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal