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Phase III Study Evaluating Topical Benzocaine for Treatment of Acute Otitis Media in Children

NCT03116737 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2017-10-13

No results posted yet for this study

Summary

The Phase III study is designed to assess the safety, tolerability, and efficacy of Topical Benzocaine in children, ages 5 to 12 years, presenting with Acute Otitis Media-associated ear pain.

Conditions

  • Pain
  • Acute Otitis Media

Interventions

DRUG

Benzocaine Otic Solution

DRUG

Placebo

Sponsors & Collaborators

  • Lachlan Pharma Holdings

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-03
Primary Completion
2017-07-21
Completion
2017-07-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03116737 on ClinicalTrials.gov