Budesonide for Induction of Remission in Incomplete Microscopic Colitis

• Status: Completed
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Falk Pharma GmbH
• Treatments: Budesonide

Criteria

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