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COMPLETEDPHASE3

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

Phase III, Multicenter, Randomized, Double-Blind, Placebo- Controlled Parallel-Designed Evaluation to Assess Safety and Efficacy of Topical Benzocaine for Treatment of Pain Associated With Acute Otitis Media in Children Ages 5 to 12 Years

NCT03116737•Lachlan Pharma Holdings

View on ClinicalTrials.gov

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.

Eligibility

Age

5 - 12 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patients ages 5 to 12 years of age with a clinical diagnosis of unilateral AOM, and with ear pain (current episode \<2 weeks duration). Baseline pain entry requires a minimum score of 4 on the FPS-R.
•Patients/guardians must provide Institutional Review Board (IRB) approved written assent, as appropriate, which must be accompanied by an IRB approved written informed consent form (ICF) from the patient's legally acceptable representative (i.e., parent or guardian), as applicable. In addition, all patients or their legally acceptable representatives (i.e., parent or guardian) must sign a Health Insurance Portability and Accountability Act (HIPAA) authorization, if applicable.
•Patients must be physically active and otherwise judged to be in good health on the basis of the medical history and a limited physical examination, as determined by the Investigator.
•Females of childbearing potential must also have a negative urine human chorionic gonadotropin (hCG) pregnancy test on the Study Day, Visit 1.

Exclusion Criteria

•Patients unable or refusing to independently and consistently complete the FPS-R pain measurements.
•Patients with bilateral AOM, perforated tympanic membrane, history of a perforated tympanic membrane in the last 6 months, or if a perforated tympanic membrane could not be ruled out by speculum examination, impedance testing tympanometry, pneumatic otoscopy, or a Valsalva maneuver.
•Patients who are subsequently diagnosed with a perforated membrane during treatment are to be discontinued immediately.
•Patients with indwelling tympanostomy tubes or draining otitis in the affected ear(s), bullous lesions, erythema of the tympanic membrane without other evidence of AOM, and patients with an anatomic defect of the ear or nasopharynx.
•Complications of treated/untreated ear disease other than qualifying AOM over the past 2 weeks.
•Patients with comorbidity requiring antibiotic therapy, allergy to study medication, immunologic deficiency, and major medical condition(s).
•Patients presenting with methemoglobinemia or a history of methemoglobinemia, vertigo, inherited enzyme deficiencies (including G6PD), impaired cardiac or respiratory functions, epilepsy, heart diseases, hypersensitivity to benzocaine or any other related drug product, inflamed or infected skin, dermatitis, previous medication related shock episode, hepatic impairment, or myasthenia gravis.
•Acute or chronic otitis externa.
•Chronic otitis media (current episode ≥ 2 weeks).
•Patients who smoke.
+16 more criteria

Locations (1)

Cyn3rgy Research

Gresham, Oregon, United States

Key Dates

Start Date

January 3, 2017

Primary Completion Date

July 21, 2017

Completion Date

July 21, 2017

Last Updated

October 13, 2017

Enrollment

141

ACTUAL participants

Conditions

PainAcute Otitis Media

Interventions

Benzocaine Otic Solution

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 13, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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