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

NCT04133194 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-09-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Mesalazine

1600 mg Asacol \[mesalazine\]

DRUG

Mesalazine

800 mg Asacol \[mesalazine\]

Sponsors & Collaborators

  • Flemming Bendtsen

    lead OTHER

Principal Investigators

  • Flemming Bendtsen, MDSci · Copenhagen University Hospital, Hvidovre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-28
Primary Completion
2024-12-31
Completion
2025-03-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04133194 on ClinicalTrials.gov