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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