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Mebendazole

Phase 3

Healthy Volunteers | Small molecule | Other |Johnson & Johnson|Last Updated: Mar 12, 2014

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment397
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01173562A Safety Study of Mebendazole in Children 2 to 10 Years of AgePHASE3 COMPLETED 397 — — Feb 1, 2010Mar 1, 2010Mar 12, 20141 Tanzania
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Study Endpoints
Primary Endpoints
The number, severity, relationship to study drug, and type of adverse events reported.
Baseline (Day 1) to the end of study (Day 3) or early withdrawal visit
Secondary Endpoints
Change in physical examination
Baseline (Day 1) to the end of study (Day 3) or early withdrawal visit
Change in vital sign measurements
Baseline (Day 1) to the end of study (Day 3) or early withdrawal visit
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MebendazoleEXPERIMENTAL -
Interventions
NameTypeDescription
MebendazoleDRUGType= exact number, unit= mg, number= 500, form= chewable tablet, route= oral use. One mebendazole 500-mg chewable tablet taken on Day 1.
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Eligibility Criteria
Age Range2 Years — 10 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Be an otherwise healthy child based on medical history, physical examination, vital signs, and concomitant medications and live in a high-prevalence area where parasite infection is endemic (ie, Prevalent in or peculiar to a particular locality, region, or people) * Have teeth...

Countries:Tanzania
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