Budesonide for Induction of Remission in Incomplete Microscopic Colitis

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of active incomplete microscopic colitis.

Official Title
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Randomised, Double-blind, Placebo-controlled, Multi-centre Trial on the Efficacy and Safety of Budesonide for Induction of Remission in Incomplete Microscopic Colitis

Conditions
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Incomplete Microscopic Colitis

Intervention / Treatment
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* Drug: Budesonide granules 9 mg
* Drug: Placebo granules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically established diagnosis of incomplete microscopic colitis (MCi) History of chronic non-bloody, watery diarrhoea Clinically active disease Exclusion Criteria: Other significant abnormalities in colonoscopy Infectious cause of diarrhoea Clinical suspicion of drug-induced diarrhoea Prior and present MC History of bowel resection Radiation therapy of the abdominal or pelvic region Positive antibody titres for celiac disease Untreated active thyroid dysfunction Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder reducing life expectancy Abnormal hepatic function Tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured History of colorectal cancer History of cancer (other than colorectal) in the last 5 years Therapy with immunomodulators/budesonide or other steroids/antibiotics/anti-diarrhoeal drugs Current or intended pregnancy or breast-feeding Doubt about the patient's cooperation, e.g. because of addiction to alcohol or drugs Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Budesonide granules 9 mg | Drug: Budesonide granules 9 mg<br>* per day<br>|
| Placebo Comparator: B<br>Placebo granules | Drug: Placebo granules<br>* per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical remission |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical remission |  | 2 weeks | 
| Rate of clinical remission |  | 6 weeks | 
| Time to remission |  | 8 weeks | 
| Number of formed/soft/watery stools per week |  | 8 weeks | 
| Number of days with abdominal pain |  | 8 weeks | 
| Number of days with urgency |  | 8 weeks | 
| Rate of histological remission |  | 8 weeks | 
| Physician's global assessment at final visit |  | 8 weeks | 
| Quality of life |  | 8 weeks |