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Long-Term Treatment of Collagenous Colitis With Budesonide

NCT ID: NCT00139165

Last Updated: 2008-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-03-31

Brief Summary

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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)

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Detailed Description

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Conditions

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Collagenous Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Budesonide

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

Intervention Type DRUG

sigmoidoscopy

Sigmoidoscopy performed 2 times during the study period.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Histological criteria of Collagenous colitis
* Clinical activity (\> 3 stools/day)

Exclusion Criteria

* Treatment of Collagenous colitis within the last 3 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Bonderup, Ole K., M.D.

INDIV

Sponsor Role lead

Principal Investigators

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Ole K Bonderup, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Dept. of medical gastroenterology

Aalborg, , Denmark

Site Status

Dept. of medical gastroenterology

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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okbon123

Identifier Type: -

Identifier Source: org_study_id

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