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Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

This study has been completed.
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH Identifier:
First received: September 23, 2010
Last updated: July 25, 2017
Last verified: July 2017
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Proportion of patients with histological improvement [ Time Frame: 8 weeks ]

Enrollment: 57
Study Start Date: May 2010
Study Completion Date: June 2017
Primary Completion Date: June 2017 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT01209208

Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf
Hamburg, Germany
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Principal Investigator: Stephan Miehlke, Professor Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf, Hamburg, Germany
  More Information

Responsible Party: Dr. Falk Pharma GmbH Identifier: NCT01209208     History of Changes
Other Study ID Numbers: BUG-1/LMC
2008-005994-36 ( EudraCT Number )
Study First Received: September 23, 2010
Last Updated: July 25, 2017

Additional relevant MeSH terms:
Colitis, Lymphocytic
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Colitis, Microscopic
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Antirheumatic Agents processed this record on September 21, 2017