Budesonide for Induction of Remission in Incomplete Microscopic Colitis

Phase 3

Completed

• Conditions: Incomplete Microscopic Colitis
• Interventions: Drug: Placebo granules; Drug: Budesonide granules 9 mg

• Registration Number: NCT02142634
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-05-16
• Study First Posted: 2014-05-20
• Primary Completion: 2020-02
• Study Completion: 2020-02
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Placebo granules	Placebo granules
A	Budesonide granules 9 mg	Budesonide granules 9 mg

Primary Outcome Measures

Name	Time	Method
Rate of clinical remission	8 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Centre for Digestive Diseases; 🇩🇪 Hamburg, Germany

University Hospital of Linköping, Dept. of Gastroenterology and Hepatology; 🇸🇪 Linköping, Sweden