Essentiale® Paste in Patients With Gastrointestinal Symptoms in Acute or Chronic Liver Diseases (EPLID)
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|ClinicalTrials.gov Identifier: NCT02517385|
Recruitment Status : Completed
First Posted : August 7, 2015
Last Update Posted : July 4, 2016
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.
To assess effectiveness on symptomatic improvement in patients with gastrointestinal symptoms in acute and chronic liver diseases.
To monitor compliance.
|Condition or disease||Intervention/treatment||Phase|
|Hepatic and Hepatobiliary Disorders||Drug: Phosphatidylcholine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||147 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Phosphatidylcholine paste
One dose of phosphatidylcholine paste 600 mg given orally 3 times a day at Days 0, 28, 56, and 84
Pharmaceutical form:Paste Route of administration: Oral
- Frequency (number) of adverse events (AEs) related to the investigational drug [ Time Frame: Week 12 ]
- Change from baseline in patient percentage of global overall symptoms using Likert Scale [ Time Frame: Weeks 4, 8, and 12 ]
- Change from baseline in gastrointestinal symptom percentage score [ Time Frame: Weeks 4, 8, and 12 ]
- Percentage of patients with AEs regardless of the Investigator's assessment of relationship to the investigational drug [ Time Frame: Weeks 4, 8, and 12 ]
- Number of AEs regardless of the Investigator's assessment of relationship to the investigational drug [ Time Frame: Weeks 4, 8, and 12 ]
- Number of patients who complied with the prescribed treatment [ Time Frame: Weeks 4, 8, and 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02517385
|Moscow, Russian Federation|
|Study Director:||Clinical Sciences & Operations||Sanofi|