Klinische Forschung

Multizentrisch, KSSG als teilnehmendes Zentrum

Gastroenterologie | Hepatologie , Muskelzentrum | ALS Clinic

Abgeschlossen

2016

2018

Industrie

This is a double-blind, double-dummy, randomized, placebo- and active controlled, multi-center, comparative, 48-week, confirmative Phase III clinical trial. The trial will be conducted with three arms in the form of a parallel group comparison and will primarily serve to confirmatorily compare oral daily treatment with 3.2 g delayed-release phosphatidylcholine (LT-02) granules versus placebo for the maintenance of remission in patients with UC. The third arm, i.e. mesalamine, will serve as an internal control for assay sensitivity and will only be compared to placebo and LT-02 in an exploratory manner. This trial has an optional interim analysis after approximately the first 200 consecutive enrolled patients (full analysis set [FAS]) have reached their primary endpoint, i.e., have either reached week 48 or discontinued early. The decision to perform the interim analysis will be solely based on recruitment. The study will be performed according to a 2-stage group-sequential adaptive design with possible sample size adjustment and treatment arm selection