Budesonide for Induction of Remission in Incomplete Microscopic 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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2020-02-29

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.

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Detailed Description

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Conditions

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Incomplete Microscopic Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Budesonide granules 9 mg

Group Type EXPERIMENTAL

Budesonide granules 9 mg

Intervention Type DRUG

per day

B

Placebo granules

Group Type PLACEBO_COMPARATOR

Placebo granules

Intervention Type DRUG

per day

Interventions

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Budesonide granules 9 mg

per day

Intervention Type DRUG

Placebo granules

per day

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No