Long-Term Treatment of Collagenous Colitis With Budesonide - Tabular View

Tracking Information

First Received Date ^ICMJE

August 29, 2005

Last Updated Date

March 3, 2008

Start Date ^ICMJE

September 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Clinical symptoms

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00139165 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Histological changes

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Long-Term Treatment of Collagenous Colitis With Budesonide

Official Title ^ICMJE

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

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)

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Collagenous Colitis

Intervention ^ICMJE

Drug: Budesonide
Procedure: sigmoidoscopy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

March 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Treatment of Collagenous colitis within the last 3 months

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00139165

Responsible Party

Study ID Numbers ^ICMJE

okbon123

Study Sponsor ^ICMJE

Bonderup, Ole K., M.D.

Collaborators ^ICMJE

AstraZeneca

Investigators ^ICMJE

Principal Investigator:

Ole K Bonderup, MD

Unaffiliated

Information Provided By

Bonderup, Ole K., M.D.

Verification Date

August 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP