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Octenidine Dihydrocloride in aqueous

Phase 2

Preoperative Skin Preparation | Small molecule | Dermatology |Becton, Dickinson and Company|Last Updated: Apr 23, 2021

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment99
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03229759Evaluation of the Antimicrobial Effectiveness of an Antimicrobial ClothPHASE2 COMPLETED 99Jun 21, 2017Aug 4, 2017Apr 23, 20211 United States
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Study Endpoints
Primary Endpoints
Bacterial Count at 10 Minutes Post Application
10 minutes after application of test product
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Investigational ProductEXPERIMENTALPolyester cloth impregnated with investigational product
Vehicle Control (VC)PLACEBO_COMPARATORPolyester cloth impregnated with the vehicle control
Saline Control (SC)PLACEBO_COMPARATORSaline applied wtih polyester cloth
Interventions
NameTypeDescription
Octenidine Dihydrocloride in aqueous solutionDRUGapplication of investigational product
Vehicle ControlOTHERapplication of vehicle control
Saline ControlOTHERapplication of placebo
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Males and/or females, at least 18 years or older and of any race. * Are in good general health. * Unable to become pregnant, or willing to use an acceptable method of contraception (i.e. oral contraception, intra-uterine device \[IUD\], diaphragm, condom, abstinence, bilateral...

Countries:United States
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