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ivermectin

Phase 3

Lice Infestations | Small molecule | Other |Johnson & Johnson|Last Updated: Aug 22, 2011

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-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment812
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00819520Ivermectin in the Treatment of Head LicePHASE3 COMPLETED 812Feb 1, 2004Oct 1, 2004Aug 22, 20114 France, Ireland +2
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Study Endpoints
Primary Endpoints
Absence or presence of live head lice
Study Day 15
Secondary Endpoints
Absence or presence of live head lice at alternative Study Days.
Study Days 2, 8, 22, 29
Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product.
throughout duration of the study (+ 30 days for spontaneously reported SAEs)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IvermectinEXPERIMENTALivermectin Stromectol®)
MalathionACTIVE_COMPARATORmalathion(Prioderm®)
Interventions
NameTypeDescription
ivermectinDRUGTwo single doses of oral ivermectin 400 mcg/kg (Days 1 and 8) plus 2 single applications of placebo lotion
malathionDRUGTwo single applications of malathion 0.5% lotion (Days 1 and 8) plus 2 single doses of placebo tablets
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Eligibility Criteria
Age Range2 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Head lice infestation confirmed by detection combing by study staff * previous (within 6 weeks) use of a topical insecticide product * minimum 15kg weight * providing informed consent Exclusion Criteria: * pregnant or nursing patients * households with 7 or more infested pat...

Countries:FranceIrelandIsraelUnited Kingdom
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