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Long-Term Treatment of Collagenous Colitis With Budesonide

Primary Purpose

Collagenous Colitis

Status

Unknown status

Phase

Phase 3

Locations

Denmark

Study Type

Interventional

Intervention

Budesonide

sigmoidoscopy

About this trial

This is an interventional treatment trial for Collagenous Colitis focused on measuring Collagenous colitis, Budesonide treatment, Diarrhea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dept. of medical gastroenterology
Dept. of medical gastroenterology

Outcomes

Primary Outcome Measures

Clinical symptoms

Secondary Outcome Measures

Histological changes

Full Information

NCT ID

NCT00139165

First Posted

August 29, 2005

Last Updated

March 3, 2008

Sponsor

Bonderup, Ole K., M.D.

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00139165

Brief Title

Long-Term Treatment of Collagenous Colitis With Budesonide

Official Title

Long-Term Treatment of Collagenous Colitis With Budesonide. Prospective, Doubleblind Placebo-Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2005

Overall Recruitment Status

Unknown status

Study Start Date

September 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Bonderup, Ole K., M.D.

Collaborators

AstraZeneca

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Collagenous Colitis

Keywords

Collagenous colitis, Budesonide treatment, Diarrhea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

36 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Budesonide

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

sigmoidoscopy

Intervention Description

Sigmoidoscopy performed 2 times during the study period.

Primary Outcome Measure Information:

Title

Clinical symptoms

Secondary Outcome Measure Information:

Title

Histological changes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ole K Bonderup, MD

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept. of medical gastroenterology

City

Aalborg

ZIP/Postal Code

9100

Country

Denmark

Facility Name

Dept. of medical gastroenterology

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

Long-Term Treatment of Collagenous Colitis With Budesonide

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