Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01209208
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : July 26, 2017
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

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

Condition or disease Intervention/treatment Phase
Lymphocytic Colitis Drug: Budesonide Drug: Mesalamine Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
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
Study Start Date : May 2010
Primary Completion Date : June 2017
Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Rate of clinical remission [ Time Frame: 8 weeks ]

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Dr. Falk Pharma GmbH Identifier: NCT01209208     History of Changes
Other Study ID Numbers: BUG-1/LMC
2008-005994-36 ( EudraCT Number )
First Posted: September 27, 2010    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 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