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

NCT04133194 | Unknown Phase 4

• 1 other identifier: 1337-EASI-trial
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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-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

Ulcerative Colitis

Outcome Measures

Primary Outcomes (3)

• Medical Adherence

  Measured by drug accountability log Patients having taken ≥80 % are categorised as adherent

  through study completion, an average of 2 year

• Medical Adherence

  Measured by "Medical adherence rating scale" (MARS) Medical adherence rating scale is a self-reported medical adherence tool consisting of 5 items scored on a 5 point Likert scale (ranging from 5-25). The scale has been used in several IBD studies and a global score \> 20 indicates a good adherence.

  through study completion, an average of 2 year

• Medical Adherence

  Measured byf drug accountability log (outcome 1) and "Medical adherence rating scale" (MARS, outcome 2) separately, excl. pregnant and breastfeeding women. Further detail see outcome 1 and 2

  through study completion, an average of 2 year

Secondary Outcomes (16)

• Assessment of disease activity by Mayo Score

  through study completion, an average of 2 year

• Assessment of disease activity by the Simple clinical colitis activity index (SCCAI)

  through study completion, an average of 2 year

• Assessment of endoscopic severity by the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)

  through study completion, an average of 2 year

• Assessment of endoscopic severity by the Mayo endoscopic score

  through study completion, an average of 2 year

• Assessment of histological severity by the Geboes score

  through study completion, an average of 2 year

Study Arms (2)

1600 mg Asacol (mesalazine)

EXPERIMENTAL

1600 mg mesalazine (Asacol) treatment regimen (1 tablet per day) for a year

Drug: Mesalazine

800 mg Asacol (mesalazine)

ACTIVE COMPARATOR

800 mg mesalazine (Asacol) treatment regimen (3 tablets per day) for a year

Drug: Mesalazine

Interventions

Mesalazine DRUG

1600 mg Asacol \[mesalazine\]

1600 mg Asacol (mesalazine)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Flemming Bendtsen: lead

Study Sites (1)

Copenhagen University Hospital Hvidovre

Hvidovre, 2200, Denmark

RECRUITING

Related Publications (1)

• Nordestgaard RLM, Lo B, Bergstrom R, Adzioski I, Skotte H, Hawwa IM, Holme SK, Tiftikci B, Majchrzak K, Vind I, Bendtsen F, Burisch J. Clinical Trial: Evaluating a Single 1600 mg Tablet Regimen of 5-Aminosalicylate for Ulcerative Colitis-The EASI Trial. Aliment Pharmacol Ther. 2025 Nov;62(9):877-886. doi: 10.1111/apt.70375. Epub 2025 Sep 16.

  PMID: 40955556 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Flemming Bendtsen, MDSci

  Copenhagen University Hospital, Hvidovre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Flemming Bendtsen, MDSci

CONTACT

+45 38623273; Flemming.Bendtsen@regionh.dk

Bobby Lo, MD

CONTACT

bobby.lo@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Senior doctor, MDSci

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 21, 2019
• Study Start: November 28, 2019
• Primary Completion: December 31, 2024
• Study Completion: March 1, 2025
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

DK (1)