Long-Term Treatment of Collagenous Colitis With Budesonide

Bonderup, Ole K., M.D.36 enrolled

Overview

The aim of the trial is to examine the effect of budesonide treatment on collagenous colitis. All patients is treated for 6 weeks with budesonide and thereafter randomised to 24 weeks treatment with placebo or continued budesonide. The end poit is effect on clinical symptoms (number of daily stools)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Collagenous Colitis

Interventions

BudesonideDRUG

Capsule. Oral 6 mg o.d. for 24 weeks

sigmoidoscopyPROCEDURE

Sigmoidoscopy performed 2 times during the study period.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histological criteria of Collagenous colitis * Clinical activity (\> 3 stools/day) Exclusion Criteria: * Treatment of Collagenous colitis within the last 3 months

Locations (2)

Dept. of medical gastroenterology

Aalborg, Denmark

Dept. of medical gastroenterology

Aarhus, Denmark

Outcomes

Primary Outcomes

Clinical symptoms

Secondary Outcomes

Histological changes

Data from ClinicalTrials.gov

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