Budesonide for Induction of Remission in Incomplete Microscopic Colitis

Dr. Falk Pharma

Status and phase: Completed; Phase 3

Conditions: Incomplete Microscopic Colitis

Treatments: Drug: Placebo granules; Drug: Budesonide granules 9 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02142634

2013-001912-31 (EudraCT Number)

BUG-3/MIC

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Budesonide granules 9 mg

Treatment:

Drug: Budesonide granules 9 mg

B

Placebo Comparator group

Description:

Placebo granules

Treatment:

Drug: Placebo granules