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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

468 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-21

Study Completion Date

2016-12-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LT-02

LT-02 0.8g four times daily

Group Type EXPERIMENTAL

LT-02

Intervention Type DRUG

four times per day

B: LT-02

LT-02 1.6g twice daily

Group Type EXPERIMENTAL

LT-02

Intervention Type DRUG

two times per day

Placebo

LT-02 Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

four times per day

Interventions

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LT-02

four times per day

Intervention Type DRUG

LT-02

two times per day

Intervention Type DRUG

Placebo

four times per day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No