Incomplete Microscopic Colitis
Conditions
Brief summary
The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of active incomplete microscopic colitis.
Interventions
DRUGBudesonide granules 9 mg
per day
DRUGPlacebo granules
per day
Sponsors
Dr. Falk Pharma GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of clinical remission | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time to remission | 8 weeks |
| Number of formed/soft/watery stools per week | 8 weeks |
| Number of days with abdominal pain | 8 weeks |
| Rate of clinical remission | 2 weeks |
| Rate of histological remission | 8 weeks |
| Physician's global assessment at final visit | 8 weeks |
| Quality of life | 8 weeks |
| Number of days with urgency | 8 weeks |
Countries
Germany, Sweden
Outcome results
None listed