Status:
UNKNOWN
Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis
Lead Sponsor:
Flemming Bendtsen
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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-adheren...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04133194
Start Date
November 28 2019
End Date
March 1 2025
Last Update
September 26 2023
Active Locations (1)
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1
Copenhagen University Hospital Hvidovre
Hvidovre, Denmark, 2200