临床试验/NCT02517385

NCT02517385已完成3 期

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 个研究点目标入组 147 人开始时间: 2015年8月最近更新: 2016年7月4日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Sanofi
入组人数: 147
主要终点: Frequency (number) of adverse events (AEs) related to the investigational drug

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 66 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

Phosphatidylcholine paste

Experimental

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

干预措施: Phosphatidylcholine (Drug)

结局指标

主要结局

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

时间窗: Week 12

次要结局

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)

研究者

发起方

Sanofi

申办方类型

Industry

责任方

Sponsor

相似试验

已完成

4 期

Efficacy and Safety of Polyene Phosphatidylcholine in Treatment of Patients With Acute Drug-induced Liver InjuryAcute Drug Induced Liver Injury

NCT04595916Sichuan Haisco Pharmaceutical Group Co., Ltd73

终止

1 期

Safety and Drug Absorption of Orally Administered Oleylphosphocholine (OlPC) in Healthy AdultsLeishmaniasis

NCT06124144University Hospital Tuebingen13

终止

3 期

A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC)Ulcerative Colitis

NCT02849951Prometheus Laboratories25

撤回

2 期

Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.Ulcerative Colitis

NCT00259571Heidelberg University

Unknown

2 期

Efficacy and Safety Evaluation of PC-SOD for Injection in Reducing Myocardial Reperfusion InjuryMyocardial Reperfusion Injury

NCT03995732Beijing Tide Pharmaceutical Co., Ltd120