Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis
Status:
Recruiting
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
Summary
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:
- Compare levels of endoscopic, mucosal and histological inflammation in predicting risk
of relapse between the intervention group and the conventional therapy group.
- Investigate whether a simplified treatment regimen improves the disease course compared
to the conventional therapy.
- To assess the correlation between different endpoints and the disease courses, with the
use of clinical, endoscopic, histological, self-reported and biochemical markers.
- Improve, correlate and assess patient-reported outcomes in a prospective manner.
- To establish a biobank of cases with quiescent/mild ulcerative colitis (UC) for
identification of future biomarkers.
Phase:
Phase 4
Details
Lead Sponsor:
Copenhagen University Hospital, Hvidovre Flemming Bendtsen