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Benzocaine

Phase 3

Sore Throat | Small molecule | Other |Johnson & Johnson|Last Updated: Oct 18, 2018

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 Enrollment260
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03432923A Study to Determine the Efficacy and Safety of a Benzocaine Lozenge for Treatment of Sore Throat.PHASE3 COMPLETED 260Feb 2, 2018Apr 21, 2018Oct 18, 201819 Russia
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Study Endpoints
Primary Endpoints
Time to meaningful pain relief.
3 hours

A timer is started upon the intake of a single dose and stopped when the subject considers he/she has experienced meaningful pain relief.

Secondary Endpoints
Time to perceptible pain relief (onset of therapeutic effect).
3 hours
Change from baseline in sore throat pain intensity self-ratings at 2.5, 5, 7.5, 10 and 15 min after intake, respectively.
15 minutes
Mean change from baseline in sore throat pain intensity self-ratings based on all assessments up to 15, 30, 60, 120, and 180 min after intake as well as during the second (60+ to 120 min) and third hour (120+ to 180 min) after intake, respectively.
3 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Benzocaine 8 mgEXPERIMENTALBenzocaine 8 mg, oval, white to slightly beige to yellow film coated tablet. One lozenge to be dissolved slowly in the mouth every 2 hours. Max 6 per day, max treatment 5 days.
PlaceboPLACEBO_COMPARATORPlacebo, oval, white to slightly beige to yellow film coated tablet. One lozenge to be dissolved slowly in the mouth every 2 hours. Max 6 per day, max treatment 5 days.
Interventions
NameTypeDescription
Benzocaine 8 mgDRUGBenzocaine 8 mg, oval, white to slightly beige to yellow film coated tablet. One lozenge to be dissolved slowly in the mouth every 2 hours. Max 6 per day, max treatment 5 days.
PlaceboDRUGPlacebo, oval, white to slightly beige to yellow film coated tablet. One lozenge to be dissolved slowly in the mouth every 2 hours. Max 6 per day, max treatment 5 days.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

Subject Inclusion Criteria Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Subjects of 18 years of age or older, suffering from throat pain caused by acute upper respiratory tract infection; 2. Symptoms of acute throat pain have been pers...

Countries:Russia
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