Randomised, double-blind, placebo-controlled, multi-centre trial on the efficacy and safety of budesonide for induction of remission in incomplete microscopic colitis - Budesonide for induction of remission in incomplete microscopic colitis
- Conditions
- Patients with active incomplete microscopic colitisMedDRA version: 20.0Level: PTClassification code 10056979Term: Colitis microscopicSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2013-001912-31-PT
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 44
1. Signed informed consent
2. Man or woman between 18 and 80 years of age
3. Histologically established diagnosis of incomplete microscopic colitis
4. History of chronic non-bloody, watery diarrhoea for at least 4 weeks
5. Clinically active disease
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26
1. Other significant abnormalities in colonoscopy that may have been the cause of diarrhoea
2. Infectious cause of diarrhoea
3. Clinical suspicion of drug-induced diarrhoea
4. Prior and present MC
5. History of bowel resection
6. Radiation therapy of the abdominal or pelvic region
7. Positive antibody titres for celiac disease
8. History of colorectal cancer
9. Therapy with immunomodulators within the last 3 months
10. Treatment with budesonide, other steroids or antibiotics within the last 4 weeks
11. Treatment with anti-diarrhoeal drugs, bulking agents, and spasmolytics within the last 2 weeks
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method