Budesonide Treatment for Lymphocytic Colitis

This study is currently recruiting participants.

Verified by Dresden University of Technology, July 2005

First Received: September 9, 2005 Last Updated: February 12, 2007 History of Changes

Sponsor:	Dresden University of Technology
Collaborator:	Dr. Falk Pharma GmbH
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00180050

Purpose

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

Condition	Intervention	Phase
Microscopic Colitis	Drug: Budesonide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy and Safety of Budesonide for Treatment of Lymphocytic Colitis

Resource links provided by NLM:

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:

Proportion of patients in clinical remission after 6 weeks

Secondary Outcome Measures:

safety
quality of life
histological improvement

Estimated Enrollment:	40
Study Start Date:	January 2002
Estimated Study Completion Date:	August 2005

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180050

Contacts

Contact: Stephan Miehlke, Prof.	+49 351 458 ext 5645	stephan.miehlke@uniklinikum-dresden.de
Contact: Ahmed Madisch, MD	+49 351 458 ext 4780	ahmed.madisch@uniklinikum-dresden.de

Locations

Germany
Medical Department I, Technical University Hospital	Recruiting
Dresden, Germany, 01307
Contact: Stephan Miehlke, Prof. +49 351 458 ext 5645 stephan.miehlke@uniklinikum-dresden.de
Contact: Ahmed Madisch, MD +49 351 458 ext 4780 ahmed.madisch@uniklinikum-dresden.de
Principal Investigator: Stephan Miehlke, Prof.

Sponsors and Collaborators

Dresden University of Technology

Dr. Falk Pharma GmbH

Investigators

Principal Investigator:

Stephan Miehlke, Prof.

Medical Department I, Technical University Hospital, Dresden, Germany

More Information

No publications provided

Study ID Numbers:	BLYCK
Study First Received:	September 9, 2005
Last Updated:	February 12, 2007
ClinicalTrials.gov Identifier:	NCT00180050 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

lymphocytic colitis
microscopic colitis
budesonide

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Colitis, Microscopic
Gastrointestinal Diseases
Colonic Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Intestinal Diseases
Hormones

Glucocorticoids
Colitis, Lymphocytic
Pharmacologic Actions
Digestive System Diseases
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Gastroenteritis
Colitis
Bronchodilator Agents

ClinicalTrials.gov processed this record on November 09, 2009