Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis
Sponsor
Dr. Falk Pharma GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT01209208
Collaborator
(none)
57
1
3
85
0.7
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
57 participants
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
Study Start Date
:
May 1, 2010
Actual Primary Completion Date
:
Jun 1, 2017
Actual Study Completion Date
:
Jun 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Rate of clinical remission [8 weeks]
Secondary Outcome Measures
- Proportion of patients with histological improvement [8 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01209208
Other Study ID Numbers:
- BUG-1/LMC
- 2008-005994-36
First Posted:
Sep 27, 2010
Last Update Posted:
Jul 26, 2017
Last Verified:
Jul 1, 2017