Long-Term Treatment of Collagenous Colitis With Budesonide

Collagenous Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00139165
• Other study ID #: okbon123
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 29, 2005
• Last updated: March 3, 2008
• Start date: September 2004
• Est. completion date: March 2006

Study information

• Verified date: August 2005
• Source: Bonderup, Ole K., M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histological criteria of Collagenous colitis

• Clinical activity (> 3 stools/day)

Exclusion Criteria:

• Treatment of Collagenous colitis within the last 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Collagenous Colitis

Intervention

Drug:
• Budesonide
Capsule. Oral 6 mg o.d. for 24 weeks

Procedure:
• sigmoidoscopy
Sigmoidoscopy performed 2 times during the study period.

Locations

Country	Name	City	State
Denmark	Dept. of medical gastroenterology	Aalborg
Denmark	Dept. of medical gastroenterology	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Bonderup, Ole K., M.D.	AstraZeneca

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical symptoms
Secondary	Histological changes