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Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis

2019-10-24 12:49:27 | BioPortfolio

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.

Study Design

Conditions

Ulcerative Colitis

Intervention

Mesalazine, Mesalazine

Status

Not yet recruiting

Source

Copenhagen University Hospital, Hvidovre

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-24T12:49:27-0400

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