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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01209208

Enrollment

Registered

2010-09-27

Start date

2010-05-31

Completion date

2017-06-30

Last updated

2017-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphocytic Colitis

Brief summary

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

Interventions

DRUGBudesonide

9 mg per day

DRUGMesalamine

3 g per day

OTHERPlacebo

0 g per day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
Rate of clinical remission	8 weeks

Secondary

Measure	Time frame
Proportion of patients with histological improvement	8 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026