Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis
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
2 other identifiers
interventional
57
1 country
1
Brief Summary
The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of lymphocytic colitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2010
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 23, 2010
CompletedFirst Posted
Study publicly available on registry
September 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJuly 26, 2017
July 1, 2017
7.1 years
September 23, 2010
July 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of clinical remission
8 weeks
Secondary Outcomes (1)
Proportion of patients with histological improvement
8 weeks
Study Arms (3)
A
EXPERIMENTALBudesonide
B
EXPERIMENTALMesalazine
C
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Symptoms and signs of indication of lymphocytic colitis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf
Hamburg, Germany
Related Publications (1)
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.
PMID: 30195447DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephan Miehlke, Professor
Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf, Hamburg, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2010
First Posted
September 27, 2010
Study Start
May 1, 2010
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
July 26, 2017
Record last verified: 2017-07