Single tablet treatment for ulcerative colitis
Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI-trial)
This study tests if a new single tablet treatment for ulcerative colitis helps patients stick to their medication better than taking multiple pills while keeping their symptoms under control.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Copenhagen University Hospital, Hvidovre Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Hvidovre) |
| Trial ID | NCT04133194 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the adherence to a new formulation of mesalazine (5-ASA) that allows patients to take a single 1600 mg tablet daily, compared to traditional multi-tablet regimens. The study aims to determine if this simplified treatment improves patient adherence while maintaining remission rates. Additionally, it will assess the levels of inflammation in the gut to predict relapse risks between the new and conventional therapies. The trial focuses on patients diagnosed with ulcerative colitis who have been stable on 5-ASA treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with a diagnosis of ulcerative colitis in stable remission on 5-ASA treatment.
Not a fit: Patients with active infections, those on immunomodulators or biological therapies, or with severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance patient adherence and improve overall management of ulcerative colitis.
How similar studies have performed: Previous studies have shown that simplified medication regimens can improve adherence, suggesting potential success for this approach.
Eligibility criteria
Show full 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
Where this trial is running
Hvidovre
- Copenhagen University Hospital Hvidovre — Hvidovre, Denmark (Recruiting)
Study contacts
- Principal investigator: Flemming Bendtsen, MDSci — Copenhagen University Hospital, Hvidovre
- Study coordinator: Flemming Bendtsen, MDSci
- Email: Flemming.Bendtsen@regionh.dk
- Phone: +45 38623273
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.