Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

Lymphocytic Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209208
• Other study ID #: BUG-1/LMC
• Secondary ID: 2008-005994-36
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2010
• Last updated: July 25, 2017
• Start date: May 2010
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Lymphocytic Colitis

Intervention

Drug:
• Budesonide
9 mg per day
• Mesalamine
3 g per day

Other:
• Placebo
0 g per day

Locations

Country	Name	City	State
Germany	Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of clinical remission		8 weeks
Secondary	Proportion of patients with histological improvement		8 weeks