Project

PCG-4/UCR

Completed · 2016 until 2018

Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Completed
Start Date
2016
End Date
2018
Financing
Industry
Study Design
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
Brief description/objective

Randomized, double-blind, double-dummy, placebo-controlled, Phase III
clinical trial on the efficacy and safety of a 48-weeks treatment with gastroresistant
phosphatidylcholine (LT-02) versus placebo versus mesalamine
for maintenance of remission in patients with ulcerative colitis