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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 60 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04133194
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Copenhagen University Hospital, Hvidovre
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Flemming Bendtsen, MDSci
Principal Investigator Affiliation Copenhagen University Hospital, Hvidovre
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Flemming Bendtsen, MDSci

Flemming.Bendtsen@regionh.dk

+45 38623273

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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