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Nabilone

Phase 2

Postoperative Nausea and Vomiting | Small molecule | Other |Unity Biotechnology, Inc.|Last Updated: Dec 3, 2015

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment331
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02115529Study of Prevention of Postoperative Nausea and Vomiting Using CesametPHASE2 COMPLETED 331Apr 1, 2014Nov 1, 2015Dec 3, 20151 Canada
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Study Endpoints
Primary Endpoints
Incidence of postoperative nausea and/or vomiting
Prior to discharge from postanesthesia care unit, an expected average of two hours
Secondary Endpoints
Number of antiemetic rescue medications given postoperatively.
Prior to discharge from postanesthesia care unit, an expected average of two hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Cesamet (nabilone)ACTIVE_COMPARATOR0.5 mg capsule containing Cesamet (single dose) given preoperatively
PlaceboPLACEBO_COMPARATORidentical capsule containing placebo (single dose) given preoperatively
Interventions
NameTypeDescription
NabiloneDRUGNabilone (0.5 mg) or placebo given preoperatively
PlaceboDRUGPlacebo Comparator: identical capsule containing placebo (single dose) given preoperatively
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age 18 or older with an American Society of Anesthesiologists (ASA) physical status of I to III who are scheduled to undergo elective surgery under general anesthesia with pre-anesthesia consultation prior to surgery. * Subjects must be able to swallow study medication; * At a...

Countries:Canada
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