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Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

Primary Purpose

Lymphocytic Colitis

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Budesonide
Mesalamine
Placebo
Sponsored by
Dr. Falk Pharma GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphocytic Colitis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

A

B

C

Arm Description

Budesonide

Mesalazine

Outcomes

Primary Outcome Measures

Rate of clinical remission

Secondary Outcome Measures

Proportion of patients with histological improvement

Full Information

First Posted
September 23, 2010
Last Updated
July 25, 2017
Sponsor
Dr. Falk Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01209208
Brief Title
Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis
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 Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Falk Pharma GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphocytic Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Budesonide
Arm Title
B
Arm Type
Experimental
Arm Description
Mesalazine
Arm Title
C
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Description
9 mg per day
Intervention Type
Drug
Intervention Name(s)
Mesalamine
Intervention Description
3 g per day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
0 g per day
Primary Outcome Measure Information:
Title
Rate of clinical remission
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients with histological improvement
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Miehlke, Professor
Organizational Affiliation
Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf, Hamburg, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf
City
Hamburg
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
30195447
Citation
Miehlke S, Aust D, Mihaly E, Armerding P, Bohm G, Bonderup O, Fernandez-Banares F, Kupcinskas J, Munck LK, Rehbehn KU, Nacak T, Greinwald R, Munch A; BUG-1/LMC Study Group. Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis. Gastroenterology. 2018 Dec;155(6):1795-1804.e3. doi: 10.1053/j.gastro.2018.08.042. Epub 2018 Sep 7.
Results Reference
derived

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Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

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