Budesonide for Maintenance Treatment of Collagenous Colitis

NCT ID: NCT00180076

Last Updated: 2010-03-30

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2008-03-31

Brief Summary

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

Detailed Description

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

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* collagenous colitis
* diarrhea
* 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
* drug and/or alcohol abuse
* lack of compliance
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role lead

Principal Investigators

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Stephan Miehlke, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical Department I, Technical University Hospital, Dresden, Germany

Locations

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Medical Department I, Technical University Hospital

Dresden, , Germany

Site Status

Countries

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Germany

Other Identifiers

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MIMIC

Identifier Type: -

Identifier Source: org_study_id

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