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

NCT03116737 | Completed Phase 3 FDA Drug

• 1 other identifier: LP7700
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

AOM

Outcome Measures

Primary Outcomes (1)

• Summed Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R)

  60 minutes

Secondary Outcomes (7)

• 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

  Up to 3 days

Study Arms (2)

Benzocaine Otic Solution

EXPERIMENTAL

Drug: Benzocaine Otic Solution

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Benzocaine Otic Solution DRUG

Benzocaine Otic Solution

Placebo DRUG

Also known as: Topical otic solution

Placebo

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lachlan Pharma Holdings: lead

Study Sites (1)

Cyn3rgy Research

Gresham, Oregon, 89104, United States

Location

MeSH Terms

Conditions

Pain; Otitis Media

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 17, 2017
• Study Start: January 3, 2017
• Primary Completion: July 21, 2017
• Study Completion: July 21, 2017
• Last Updated: October 13, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)