Clinical Trials Directory

Trials / Terminated

TerminatedNCT02142725

Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative Colitis

Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 12-weeks add-on Treatment With LT 02 vs. Placebo in Patients With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine

Status
Terminated
Phase
Phase 3
Study type
Interventional
Enrollment
468 (actual)
Sponsor
Dr. Falk Pharma GmbH · Industry
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to compare two different dosing regimens of phosphatidylcholine versus placebo for the induction of remission in ulcerative colitis patients non-responsive to standard mesalamine treatment.

Conditions

Interventions

TypeNameDescription
DRUGLT-02four times per day
DRUGLT-02two times per day
DRUGPlacebofour times per day

Timeline

Start date
2014-07-21
Primary completion
2016-11-11
Completion
2016-12-16
First posted
2014-05-20
Last updated
2017-02-09

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT02142725. Inclusion in this directory is not an endorsement.

Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative Colitis (NCT02142725) · Clinical Trials Directory