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Prucalopride

Phase 2

Postoperative Ileus | Small molecule | Other |China Pharma Holdings, Inc.|Last Updated: Sep 30, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment110
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02004652Prucalopride for Postoperative Ileus in Patients Undergoing Gastrointestinal SurgeryPHASE2 COMPLETED 110 — — Nov 1, 2013Dec 1, 2014Sep 30, 20161 China
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Study Endpoints
Primary Endpoints
Time to defaecation, measured in hours, from the time the surgery ends till the first observed passage of stool
up to 30 days after surgery
Secondary Endpoints
Time of first passing flatus reported by the patients(hours)
up to 30 days after surgery
Time to resume solid diet or total enteral nutrition(TEN)(days)
up to 30 days after surgery
Length of postoperative hospital stay (LOS)(days)
participants will be followed for the duration of postoperative hospital stay, an expected average of 8 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PrucaloprideEXPERIMENTALPrucalopride, 2mg, tablet. First given 24 hours after surgery beginning on POD 1,until bowel movements or for a maximum of 7 days of postoperative treatment
PlaceboPLACEBO_COMPARATORVitamin C, 50mg, tablet
Interventions
NameTypeDescription
PrucaloprideDRUGPrucalopride, 2mg, tablet. First given 24 hours after surgery beginning on POD 1,until bowel movements or for a maximum of 7 days of postoperative treatment
PlaceboDRUGVitamin, 50mg, tablet.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Consecutive patients undergoing elective gastric, small bowel, or partial colonic resection via laparotomy or laparoscopy. 2. Patients with American Society of Anaesthesiologists grading I-III 3. Informed consent available. Exclusion Criteria: 1. Patients with stoma creatio...

Countries:China
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