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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-28

Study Completion Date

2025-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Single-Center Observational Study on the Impact of Symptom Assessment Timing on the Short-Term Efficacy of 5-ASA Therapy in Patients With Initial-Onset or Relapsed Mild-to-Moderate Active Ulcerative Colitis

NCT06998693

Ul

COMPLETED

The Colitis Once Daily Asacol Study

NCT00708656

Ulcerative Colitis

COMPLETED PHASE3

Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis

NCT00408174

Inflammatory Bowel Disease Ulcerative Colitis

COMPLETED PHASE3

A Study of a Single Dose of ASP3291 in Subjects With Ulcerative Colitis

NCT01320332

Ulcerative Colitis

COMPLETED PHASE1

Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative Colitis

NCT01612039

Ulcerative Colitis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ulcerative Colitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1600 mg Asacol (mesalazine)

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

Group Type EXPERIMENTAL

Mesalazine

Intervention Type DRUG

1600 mg Asacol \[mesalazine\]

800 mg Asacol (mesalazine)

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

Group Type ACTIVE_COMPARATOR

Mesalazine

Intervention Type DRUG

800 mg Asacol \[mesalazine\]

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mesalazine

1600 mg Asacol \[mesalazine\]

Intervention Type DRUG

Mesalazine

800 mg Asacol \[mesalazine\]

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No