Kantonsspital St.Gallen


Claudia Krieger Grübel

abstract 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
type of project clinical studies
status completed
start of project 2016
end of project 2018
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
responsible person Prof. Stephan Brand