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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Acute Otitis Media
• Intervention / Treatment: Drug: Placebo; Drug: Benzocaine Otic Solution

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Gresham, Oregon, United States, 89104
      • Cyn3rgy Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
• Dermatitis involving the affected external ear canal or pinna.
• Any topical or systemic antibiotic received within the 14 days prior to study entry.
• Patients administered vaccinations a week prior to or on any of the Study Day Visits.
• Any ear drops, topical drying agent or over-the-counter (OTC) therapy for any ear related issue received within 36 hours prior to enrollment.
• Fever >102°F or at any elevated level considered necessary by the study investigator.
• Known hypersensitivity to the study drug or similar compounds including any of the inactive ingredients.
• Patients receiving medication on a chronic basis for pain (including steroidal or non-steroidal anti-inflammatory drugs).
• Oral analgesics such as ibuprofen/acetaminophen within 6 hours prior to study entry.
• Use of drug products with potential interactions including sulfonamides, aminosalicylates, anti-cholinesterases, suxamethonium, antiarrhythmics, monoamine oxidase inhibitors, or tricyclic antidepressants within 14 days.
• Eating, drinking, chewing of gum, or use of mints/lozenges during the first hour after initial study dose.
• Children that use pacifiers and/or are still breastfed.
• Exposure to any investigational agent within the 30 days prior to study entry.
• Previous enrollment in this study.
• Pregnant or lactating.
• Clinically significant mental or emotional illnesses (by history or as determined by the on-site investigator).
• The child has a condition or demonstrates a behavior that the Investigator or site personnel believe would interfere with the ability to provide assent (age appropriate) or comply with study instructions/tasks, or that might confound the interpretation of the study results, or put the child or others at risk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Other Names: Topical otic solution
Experimental: Benzocaine Otic Solution	Drug: Benzocaine Otic Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Summed Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R)	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Summed Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R)		120 minutes
Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R)		Up to 3 days
Dosing Intervals		Up to 3 days
Use of Rescue Medications		Up to 3 days
Assess the Safety and Tolerability of Benzocaine Based on Reported Adverse Events	Safety will be assessed by adverse event reporting on all study days. Fisher's exact test will be used to compare adverse event rates between treatment groups for the following categories: 1) all adverse events; 2) treatment related adverse events; 3) severe adverse events; 4) serious adverse events; 5) discontinuation due to adverse event.	Up to 3 days
Assess the Safety and Tolerability of Benzocaine Based on Physical Examinations	Physical examinations will be assessed. For each body system of the physical examination, the shift from normal/abnormal will be presented by treatment group as the number and percentage of children.	Up to 3 days
Assess the Safety and Tolerability of Benzocaine Based on Vital Signs	Vital signs (blood pressure, pulse, temperature, and respiratory rate) will be assessed. Descriptive statistics will be presented for the vital signs measurements collected, as well as the vital sign changes from Day 1 to Day 3 by treatment group.	Up to 3 days

Collaborators and Investigators

• Sponsor: Lachlan Pharma Holdings

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2017
• Primary Completion (Actual): July 21, 2017
• Study Completion (Actual): July 21, 2017

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 17, 2017

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: AOM
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Benzocaine
• Other Study ID Numbers: LP7700

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No