Multicenter Prospective Uncontrolled Non-comparative Open Interventional Clinical Study of Phase III for Assessment of the Safety and Effectiveness of Using the Drug Phosphatidylcholine Paste 600 mg in Patients With Acute and Chronic Liver Diseases and Clinical Symptoms of Dysfunction of the Gastrointestinal Tract During 12-week Therapy Course

Sanofi0 sites147 target enrollmentAugust 2015

ConditionsHepatic and Hepatobiliary Disorders

InterventionsPhosphatidylcholine

DrugsPhosphatidylcholine

Overview

Phase: Phase 3
Intervention: Phosphatidylcholine
Conditions: Hepatic and Hepatobiliary Disorders
Sponsor: Sanofi
Enrollment: 147
Primary Endpoint: Frequency (number) of adverse events (AEs) related to the investigational drug
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Detailed Description

The total study duration per patient will be 13 weeks that consists of 1-week pre-screening period and a 12-week treatment period.

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

June 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sanofi

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Phosphatidylcholine paste

One dose of phosphatidylcholine paste 600 mg given orally 3 times a day at Days 0, 28, 56, and 84

Intervention: Phosphatidylcholine

Outcomes

Primary Outcomes

Frequency (number) of adverse events (AEs) related to the investigational drug

Time Frame: Week 12

Secondary Outcomes

Change from baseline in patient percentage of global overall symptoms using Likert Scale(Weeks 4, 8, and 12)
Change from baseline in gastrointestinal symptom percentage score(Weeks 4, 8, and 12)
Number of AEs regardless of the Investigator's assessment of relationship to the investigational drug(Weeks 4, 8, and 12)
Number of patients who complied with the prescribed treatment(Weeks 4, 8, and 12)
Percentage of patients with AEs regardless of the Investigator's assessment of relationship to the investigational drug(Weeks 4, 8, and 12)