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GW679769

Phase 3

Nausea and Vomiting, Postoperative | Small molecule | Other |GSK plc|Last Updated: Oct 26, 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-BlindUNCONTROLLED
Total Trials1
Total Enrollment482
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00326248Casopitant (Oral) And ZOFRAN To Prevent Postoperative Nausea And Vomiting In WomenPHASE3 COMPLETED 482Mar 1, 2006Jul 1, 2006Oct 26, 201658 United States, Canada +9
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Study Endpoints
Primary Endpoints
Rates of vomiting and retching
after surgery
Secondary Endpoints
Rates of nausea. Blood test results.
after surgery
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTAL -
Interventions
NameTypeDescription
GW679769 (casopitant)DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites58

Inclusion criteria: * History of PONV and/or motion sickness. * Have not smoked for the last 6 months. * Having certain types of abdominal, breast or shoulder surgeries. Exclusion criteria: * Pregnant or breastfeeding. * Taking certain medications. * Have certain pre-existing medical conditions.

Countries:United StatesCanadaFranceGermanyHong KongHungaryIrelandPakistanPhilippinesThailandUnited Kingdom
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