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Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 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: February 6, 2017
Last verified: February 2017
  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
Intervention Model: Parallel Assignment
Masking: 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 ]

Estimated Enrollment: 75
Study Start Date: May 2010
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: May 2017 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov 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: February 6, 2017

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

ClinicalTrials.gov processed this record on March 24, 2017