Trials / Completed
CompletedNCT02517385
Essentiale® Paste in Patients With Gastrointestinal Symptoms in Acute or Chronic Liver Diseases
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 147 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years – 66 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Phosphatidylcholine | Pharmaceutical form:Paste Route of administration: Oral |
Timeline
- Start date
- 2015-08-01
- Primary completion
- 2016-06-01
- Completion
- 2016-06-01
- First posted
- 2015-08-07
- Last updated
- 2016-07-04
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT02517385. Inclusion in this directory is not an endorsement.