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Clinical Trials/NCT00180076
NCT00180076
Completed
Phase 3

Efficacy and Safety of Budesonide in Maintenance Treatment of Collagenous Colitis

Technische Universität Dresden1 site in 1 country75 target enrollmentJuly 2004
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ConditionsCollagenous Colitis
DrugsBudesonide

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Collagenous Colitis
Sponsor
Technische Universität Dresden
Enrollment
75
Locations
1
Primary Endpoint
Proportion of patients in clinical remission after 6 months
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 maintaining clinical remission in patients with collagenous colitis.

Detailed Description

The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.

Registry
clinicaltrials.gov
Start Date
July 2004
End Date
March 2008
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •collagenous colitis
  • •written informed consent

Exclusion Criteria

  • •infectious causes for diarrhea
  • •other inflammatory bowel diseases
  • •history of colonic surgery
  • •celiac disease
  • •malignancies
  • •severe concomitant diseases
  • •use of budesonide, steroids, mesalazine within the previous 2 weeks
  • •known intolerance to budesonide
  • •history of lack of response to budesonide
  • •pregnancy,lactation

Outcomes

Primary Outcomes

Proportion of patients in clinical remission after 6 months

Secondary Outcomes

  • time to relapse
  • safety
  • quality of life
  • histological improvement

Study Sites (1)

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