Budesonide for Induction of Remission in Incomplete Microscopic Colitis

July 21, 2020 updated by: Dr. Falk Pharma GmbH

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20249
        • Centre For Digestive Diseases
  • Sweden
      • Linköping, Sweden, 58185
        • University Hospital of Linköping, Dept. of Gastroenterology and Hepatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Budesonide granules 9 mg
Drug: Budesonide granules 9 mg
per day
Placebo Comparator: B
Placebo granules
Drug: Placebo granules
per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of clinical remission
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Falk Pharma GmbH

Investigators

  • Principal Investigator: Andreas Münch, MD, University Hospital of Linköping, Dept. of Gastroenterology and Hepatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

May 14, 2014

First Submitted That Met QC Criteria

May 16, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUG-3/MIC
  • 2013-001912-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Incomplete Microscopic Colitis

Clinical Trials on Budesonide granules 9 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe