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

Phase 3

Completed

• Conditions: Hepatic and Hepatobiliary Disorders
• Interventions: Drug: Phosphatidylcholine

• Registration Number: NCT02517385
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study First Submitted: 2015-07-20
• Study Start: 2015-08
• Study First Submitted QC: 2015-08-04
• Study First Posted: 2015-08-07
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-01
• Last Update Posted: 2016-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Frequency (number) of adverse events (AEs) related to the investigational drug	Week 12

Secondary Outcome Measures

Name	Time	Method
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
Percentage of patients with AEs regardless of the Investigator's assessment of relationship to the investigational drug	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