Budesonide Treatment for Lymphocytic Colitis
Overview
The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis
Full Title of Study: “Efficacy and Safety of Budesonide for Treatment of Lymphocytic Colitis”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double
- Study Primary Completion Date: August 2006
Detailed Description
The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis
Interventions
- Drug: Budesonide
Clinical Trial Outcome Measures
Primary Measures
- Proportion of patients in clinical remission after 6 weeks
Secondary Measures
- safety
- quality of life
- histological improvement
Participating in This Clinical Trial
Inclusion Criteria
- lymphocytic colitis – diarrhea – effective contraception – written informed consent Exclusion Criteria:
- other forms if IBD – celiac disease – infectious colitis – history of colonic surgery – use of budesonide, 5-ASA, steroids within th previous 4 weeks – pregnancy, lactation
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Technische Universität Dresden
- Collaborator
- Dr. Falk Pharma GmbH
- Overall Official(s)
- Stephan Miehlke, Prof., Principal Investigator, Medical Department I, Technical University Hospital, Dresden, Germany
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