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Phosphatidylcholine

Phase 3

Hepatic and Hepatobiliary Disorders | Small molecule | Gastrointestinal |Sanofi|Last Updated: Jul 4, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment147
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02517385Essentiale® Paste in Patients With Gastrointestinal Symptoms in Acute or Chronic Liver DiseasesPHASE3 COMPLETED 147 — — Aug 1, 2015Jun 1, 2016Jul 4, 20161 Russia
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Study Endpoints
Primary Endpoints
Frequency (number) of adverse events (AEs) related to the investigational drug
Week 12
Secondary Endpoints
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
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phosphatidylcholine pasteEXPERIMENTALOne dose of phosphatidylcholine paste 600 mg given orally 3 times a day at Days 0, 28, 56, and 84
Interventions
NameTypeDescription
PhosphatidylcholineDRUGPharmaceutical form:Paste Route of administration: Oral
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Eligibility Criteria
Age Range18 Years — 66 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Males and females ≥18 years of age and less than 66 years old. * Patients with gastrointestinal symptoms (fatigue, abdominal pain/discomfort, early satiety, fullness discomfort after meal, nausea/vomiting, belching/abdominal distension, at least one rated as "Moderate Problem"...

Countries:Russia
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