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Benzocaine

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment260

FDA Designations

No designations recorded

Clinical trial landscape

Benzocaine · 1 trial · 1 indication

Phase 3 1
NCT03432923A Study to Determine the Efficacy and Safety of a Benzocaine Lozenge for Treatment of Sore Throat.Sore Throat
COMPLETED260 Analytics
PHASE3COMPLETED
A Study to Determine the Efficacy and Safety of a Benzocaine Lozenge for Treatment of Sore Throat.
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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 to 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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Frequently asked questions about Benzocaine

What is Benzocaine used for?

Benzocaine is a small molecule being developed for the treatment of sore throat. It is administered as a lozenge and is intended to provide relief from the discomfort associated with this condition. The drug is currently in Phase 3 clinical development.

Who makes Benzocaine?

Benzocaine is being developed by Johnson & Johnson, a company traded on the stock exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the efficacy and safety of this drug for the treatment of sore throat.

What phase is Benzocaine in?

Benzocaine is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial for this drug has been completed, and it is being studied for the treatment of sore throat.

What clinical trials is Benzocaine in?

Benzocaine has one completed Phase 3 clinical trial, identified by the NCT number NCT03432923. This trial was a randomized, double-blind, placebo-controlled study that enrolled 260 participants to evaluate the efficacy and safety of a Benzocaine lozenge for the treatment of sore throat.

Is Benzocaine FDA approved?

Benzocaine is not FDA approved for the treatment of sore throat. It is an investigational drug currently in Phase 3 clinical development. The completed clinical trial for this drug was conducted in Russia, and further regulatory review would be required before it could be considered for approval.