NCT02142634
Completed
Phase 3
Randomised, Double-blind, Placebo-controlled, Multi-centre Trial on the Efficacy and Safety of Budesonide for Induction of Remission in Incomplete Microscopic Colitis
ConditionsIncomplete Microscopic Colitis
Overview
- Phase
- Phase 3
- Intervention
- Budesonide granules 9 mg
- Conditions
- Incomplete Microscopic Colitis
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Rate of clinical remission
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of active incomplete microscopic colitis.
Investigators
Eligibility 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
Arms & Interventions
A
Budesonide granules 9 mg
Intervention: Budesonide granules 9 mg
B
Placebo granules
Intervention: Placebo granules
Outcomes
Primary Outcomes
Rate of clinical remission
Time Frame: 8 weeks
Secondary Outcomes
- Rate of clinical remission(6 weeks)
- Number of days with abdominal pain(8 weeks)
- Number of days with urgency(8 weeks)
- Rate of histological remission(8 weeks)
- Time to remission(8 weeks)
- Number of formed/soft/watery stools per week(8 weeks)
- Physician's global assessment at final visit(8 weeks)
- Quality of life(8 weeks)
Study Sites (2)
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