Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2017-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Lymphocytic Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Budesonide

Group Type EXPERIMENTAL

Budesonide

Intervention Type DRUG

9 mg per day

B

Mesalazine

Group Type EXPERIMENTAL

Mesalamine

Intervention Type DRUG

3 g per day

C

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

0 g per day

Interventions

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Budesonide

9 mg per day

Intervention Type DRUG

Mesalamine

3 g per day

Intervention Type DRUG

Placebo

0 g per day

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No