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Clinical Trials/NCT00180050
NCT00180050
Completed
Phase 3

Efficacy and Safety of Budesonide for Treatment of Lymphocytic Colitis

Technische Universität Dresden1 site in 1 country40 target enrollmentJanuary 2002
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ConditionsMicroscopic Colitis
DrugsBudesonide

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Microscopic Colitis
Sponsor
Technische Universität Dresden
Enrollment
40
Locations
1
Primary Endpoint
Proportion of patients in clinical remission after 6 weeks
Status
Completed
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis

Detailed Description

The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis

Registry
clinicaltrials.gov
Start Date
January 2002
End Date
August 2007
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •lymphocytic colitis
  • •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

Outcomes

Primary Outcomes

Proportion of patients in clinical remission after 6 weeks

Secondary Outcomes

  • safety
  • quality of life
  • histological improvement

Study Sites (1)

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