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OpenTrials
Completed

NCT Number: NCT01209208

Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

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

Completed

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Key information

Conditions

Lymphocytic Colitis Colitis Colitis, Lymphocytic Colitis, Microscopic Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf

Hamburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide

Drug

9 mg per day

Mesalamine

Drug

3 g per day

Placebo

Other

0 g per day

Primary outcomes

  1. Rate of clinical remission

    Time frame: 8 weeks

Secondary outcomes

  1. Proportion of patients with histological improvement

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Dr. Falk Pharma GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Sep 27, 2010
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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