Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

This study is currently recruiting participants.
Verified November 2013 by Dr. Falk Pharma GmbH
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
First received: September 23, 2010
Last updated: November 5, 2013
Last verified: November 2013

The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of lymphocytic colitis.

Condition Intervention Phase
Lymphocytic Colitis
Drug: Budesonide
Drug: Mesalamine
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Double-dummy, Randomised, Placebo-controlled, Multi-centre Phase III Study on the Efficacy and Tolerability of a 8-week Treatment With Budesonide vs. Mesalazine vs. Placebo in Patients With Lymphocytic Colitis

Resource links provided by NLM:

Further study details as provided by Dr. Falk Pharma GmbH:

Primary Outcome Measures:
  • Rate of clinical remission [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with histological improvement [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: May 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Drug: Budesonide
9 mg per day
Experimental: B
Drug: Mesalamine
3 g per day
Placebo Comparator: C Other: Placebo
0 g per day


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent
  • Symptoms and signs of indication of lymphocytic colitis

Exclusion Criteria:

  • Infectious diarrhoea,
  • Diarrhoea as a result of the presence of other symptomatic organic disease(s) of the gastrointestinal tract or endoscopic-histological findings Celiac disease
  • Pregnancy or breast-feeding,
  • Participation in an other clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01209208

Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf Recruiting
Hamburg, Germany
Contact: Stephan Miehlke, Professor    ++49 40 460 ext 2001    prof.miehlke@mdz-hamburg.de   
Principal Investigator: Stephan Miehlke, Professor         
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Principal Investigator: Stephan Miehlke, Professor Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf, Hamburg, Germany
  More Information

No publications provided

Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT01209208     History of Changes
Other Study ID Numbers: BUG-1/LMC, 2008-005994-36
Study First Received: September 23, 2010
Last Updated: November 5, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Colitis, Lymphocytic
Colitis, Microscopic
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 23, 2014