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

  • STATUS
    Recruiting
  • End date
    May 23, 2023
  • participants needed
    200
  • sponsor
    Copenhagen University Hospital, Hvidovre
Updated on 23 January 2021
cancer
corticosteroids
remission
mesalamine
asacol
oral mesalazine

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.

Details
Condition Ulcerative Colitis, Ulcerative Colitis (Pediatric)
Treatment mesalazine
Clinical Study IdentifierNCT04133194
SponsorCopenhagen University Hospital, Hvidovre
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
Defined as the need of escalation of treatment or change medical treatment

Exclusion Criteria

Evidence of infectious diarrhoea (i.e. pathogenic viruses, bacteria or Clostridium difficile toxin in stool culture) within the last month
On immunomodulators, including methotrexate
On any biological therapy
Any previous abdominal surgery related to UC
Any chronic infections (e.g. HBV, HCV, HIV)
Any severe concomitant cardiovascular, autoimmune, hematologic, hepatic, renal, endocrine, oncologic or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results
Well-founded doubt about the patient's cooperation, e.g., because of addiction to alcohol or drugs in the opinion of the investigators
Participation in another clinical trial within the last 30 days, or simultaneous participation in another clinical trial
Any previous documented allergic reaction to tested the medical drugs
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