Trial | NCT02142725  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    468
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.
Study Started
Jul 21
2014
Primary Completion
Nov 11
2016
Study Completion
Dec 16
2016
Last Update
Feb 09
2017
Estimate

Drug LT-02

four times per day

Drug LT-02

two times per day

Drug Placebo

four times per day

LT-02 Experimental

LT-02 0.8g four times daily

B: LT-02 Experimental

LT-02 1.6g twice daily

Placebo Placebo Comparator

LT-02 Placebo

Criteria 

Inclusion Criteria:

Established diagnosis of ulcerative colitis
Active ulcerative colitis disease extent ≥ 15 cm
Active disease despite treatment with mesalamine

Exclusion Criteria:

Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis, diverticular disease associated colitis,
Toxic megacolon or fulminant colitis
Colon resection
Evidence of infectious colitis
Celiac disease
Bleeding hemorrhoids
History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack
Any severe concomitant renal, endocrine, or psychiatric disorder
Any relevant known systemic disease
History of cancer in the last five years
Abnormal hepatic function or liver cirrhosis
Abnormal HbA1c at screening visit
Patients with known hypersensitivity to soy
Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP)
Treatment with steroids/methotrexate/Tumor necrosis factor-alpha-antagonists/azathioprine/ 6-mercaptopurine/anti-integrin/coumarins
Treatment with other investigational drug
Existing or intended pregnancy or breast-feeding
No Results Posted