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ondansetron

Phase 2

Postoperative Nausea and Vomiting | Small molecule | Other |GSK plc|Last Updated: Jan 20, 2017

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment701
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00108095A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And VomitingPHASE2 COMPLETED 701 — — Oct 1, 2004Aug 1, 2005Jan 20, 201758 United States, Belgium +4
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Study Endpoints
Primary Endpoints
Number of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, and no premature discontinuation from the study) during the first 24 hour evaluation period following emergence from anesthesia
Secondary Endpoints
Number of subjects who achieve a complete response during each subsequent 24 hour evaluation period (up to 120 hours)following the emergence from anesthesia
The extent of nausea experienced by subjects.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
intravenous ondansetronDRUG -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexFEMALE
Healthy VolunteersNo
Study Sites58

Inclusion criteria: * Females age 18-55 * Laparoscopic/laparotomic gynecological procedure of laparoscopic gallbladder removal Exclusion criteria: * Pregnant or breastfeeding * Post-menopausal * Not undergoing general anesthesia

Countries:United StatesBelgiumCanadaGermanyHungarySpain
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