Incomplete Microscopic Colitis Clinical Trial
Official title:
Randomised, Double-blind, Placebo-controlled, Multi-centre Trial on the Efficacy and Safety of Budesonide for Induction of Remission in Incomplete Microscopic Colitis
| Verified date | July 2020 |
| Source | Dr. Falk Pharma GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of active incomplete microscopic colitis.
| Status | Completed |
| Enrollment | 44 |
| Est. completion date | February 2020 |
| Est. primary completion date | February 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Centre for Digestive Diseases | Hamburg | |
| Sweden | University Hospital of Linköping, Dept. of Gastroenterology and Hepatology | Linköping |
| Lead Sponsor | Collaborator |
|---|---|
| Dr. Falk Pharma GmbH |
Germany, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of clinical remission | 8 weeks | ||
| Secondary | Rate of clinical remission | 2 weeks | ||
| Secondary | Rate of clinical remission | 6 weeks | ||
| Secondary | Time to remission | 8 weeks | ||
| Secondary | Number of formed/soft/watery stools per week | 8 weeks | ||
| Secondary | Number of days with abdominal pain | 8 weeks | ||
| Secondary | Number of days with urgency | 8 weeks | ||
| Secondary | Rate of histological remission | 8 weeks | ||
| Secondary | Physician's global assessment at final visit | 8 weeks | ||
| Secondary | Quality of life | 8 weeks |