Budesonide for Maintenance Treatment of Collagenous Colitis

Collagenous Colitis Clinical Trial

Official title:

Efficacy and Safety of Budesonide in Maintenance Treatment of Collagenous Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180076
• Other study ID #: MIMIC
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: March 29, 2010
• Start date: July 2004
• Est. completion date: March 2008

Study information

• Verified date: March 2010
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medicinal Device
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2008
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Locations

Country	Name	City	State
Germany	Medical Department I, Technical University Hospital	Dresden

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients in clinical remission after 6 months
Secondary	time to relapse
Secondary	safety
Secondary	quality of life
Secondary	histological improvement