Budesonide Treatment for Lymphocytic Colitis

Microscopic Colitis Clinical Trial

Official title:

Efficacy and Safety of Budesonide for Treatment of Lymphocytic Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180050
• Other study ID #: BLYCK
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: March 29, 2010
• Start date: January 2002
• Est. completion date: August 2007

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 Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis

Description:

The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2007
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• lymphocytic colitis

• diarrhea

• effective contraception

• written informed consent

Exclusion Criteria:

• other forms if IBD

• celiac disease

• infectious colitis

• history of colonic surgery

• use of budesonide, 5-ASA, steroids within th previous 4 weeks

• pregnancy, lactation

Study Design

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Microscopic
• Microscopic 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	Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

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