Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Presenting With Acute Otitis Media

NCT02092454 | Completed Phase 2

• 1 other identifier: OT5675
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 3

Brief Summary

To assess the clinical safety and efficacy of the Benzocaine relative to placebo in pain relief associated with acute otitis media.

Conditions

Pain; Acute Otitis Media

Outcome Measures

Primary Outcomes (1)

• Summed Pain Intensity Difference

  60 minutes

Secondary Outcomes (7)

• Pain Intensity Difference

  Up to 120 minutes

• Comparison of pain scores from AOM-SOS and FLACC pain measurement scales in patients 2 months to 4 years old

  Up to 3 days

• Comparison of pain scores from VAS and FPS-R pain measurement scales in patients 5 years to 12 years old

  Up to 3 days

• Physician Global Evaluation

  Up to 3 days

• Evaluate dosing intervals with pain measurements assessed up to 120 minutes

  Up to 120 minutes

Study Arms (2)

Benzocaine

EXPERIMENTAL

Topical otic solution, every 1-2 hours, for up to 3 days

Drug: Benzocaine

Placebo

PLACEBO COMPARATOR

Topical otic solution, every 1-2 hours, for up to 3 days

Drug: Placebo

Interventions

Benzocaine DRUG

topical otic solution

Benzocaine

Placebo DRUG

topical otic solution

Placebo

Eligibility Criteria

• Age: 2 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female patients ages 2 months to 12 years of age with a clinical diagnosis of AOM, and with ear pain (current episode \<2 weeks duration). Baseline pain entry requires a minimum score of 4 on the FLACC or the FPS-R scale (depending on age)
• The patients 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 normally 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 child bearing potential must have a negative urine human chorionic gonadotropin (hCG) pregnancy test at Visit 1

You may not qualify if:

• 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 over the past 2 weeks
• Patients with comorbidity requiring antibiotic therapy, allergy to study medication, immunologic deficiency, and major medical condition(s).
• Patients with methemoglobinemia or a history of methemoglobinemia, vertigo, inherited enzyme deficiencies, impaired cardiac or respiratory functions, epilepsy, heart diseases, hypersensitivity, pyrogenic infection at or near the skin, inflamed or infected skin, dermatitis, shock, hepatic impairment, or myasthenia gravis
• Acute or chronic otitis externa
• Chronic otitis media (current episode ≥ 2 weeks)
• Patients who smoke are prohibited from participating in this study.
• Seborrheic dermatitis involving the affected external ear canal or pinna
• Any topical or systemic antibiotic received within the 14 days prior to study entry (topical antibiotics for acne will be allowed)
• Any topical drying agent or over-the-counter (OTC) therapy for otitis media received within 36 hours prior to enrollment
• Fever \>102°F
• 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)

Sponsors & Collaborators

• Otic Therapy, LLC: lead

Study Sites (3)

Unknown Facility

Clearwater, Florida, United States

Location

Unknown Facility

Gresham, Oregon, United States

Location

Unknown Facility

Murray, Utah, United States

Location

MeSH Terms

Conditions

Pain; Otitis Media

Interventions

Benzocaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 20, 2014
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 25, 2015

Record last verified: 2015-05

Locations

US (3)