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Essentiale® Paste in Patients With Gastrointestinal Symptoms in Acute or Chronic Liver Diseases

NCT02517385 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2016-07-04

No results posted yet for this study

Summary

Primary Objective:

To assess safety of Phosphatidylcholine paste 600 mg (ESSENTIALE® paste) oral 3 times a day for 12 weeks in patients with gastrointestinal symptoms in acute and chronic liver diseases.

Secondary Objectives:

To assess effectiveness on symptomatic improvement in patients with gastrointestinal symptoms in acute and chronic liver diseases.

To monitor compliance.

Conditions

  • Hepatic and Hepatobiliary Disorders

Interventions

DRUG

Phosphatidylcholine

Pharmaceutical form:Paste Route of administration: Oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
66 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Russia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02517385 on ClinicalTrials.gov