We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01209208
First Posted: September 27, 2010
Last Update Posted: July 26, 2017
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.
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
  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: 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
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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 ClinicalTrials.gov identifier (NCT number): NCT01209208


Locations
Germany
Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf
Hamburg, Germany
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 )
First Submitted: September 23, 2010
First Posted: September 27, 2010
Last Update Posted: July 26, 2017
Last Verified: July 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