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Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

This study is currently recruiting participants.
Verified December 2012 by Dr. Falk Pharma GmbH
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01209208
First received: September 23, 2010
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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
Budesonide
 Drug: Budesonide
9 mg per day
Experimental: B
Mesalazine
 Drug: Mesalamine
3 g per day
Placebo Comparator: C Other: Placebo
0 g per day

  Eligibility

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

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

Locations
Germany
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
Investigators
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: December 5, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 16, 2013