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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03116737
Recruitment Status : Completed
First Posted : April 17, 2017
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Lachlan Pharma Holdings

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.

Condition or disease Intervention/treatment Phase
Pain Acute Otitis Media Drug: Benzocaine Otic Solution Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 3, 2017
Actual Primary Completion Date : July 21, 2017
Actual Study Completion Date : July 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Experimental: Benzocaine Otic Solution Drug: Benzocaine Otic Solution
Placebo Comparator: Placebo Drug: Placebo
Other Name: Topical otic solution




Primary Outcome Measures :
  1. Summed Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R) [ Time Frame: 60 minutes ]

Secondary Outcome Measures :
  1. Summed Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R) [ Time Frame: 120 minutes ]
  2. Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R) [ Time Frame: Up to 3 days ]
  3. Dosing Intervals [ Time Frame: Up to 3 days ]
  4. Use of Rescue Medications [ Time Frame: Up to 3 days ]
  5. Assess the Safety and Tolerability of Benzocaine Based on Reported Adverse Events [ Time Frame: Up to 3 days ]
    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.

  6. Assess the Safety and Tolerability of Benzocaine Based on Physical Examinations [ Time Frame: Up to 3 days ]
    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.

  7. Assess the Safety and Tolerability of Benzocaine Based on Vital Signs [ Time Frame: Up to 3 days ]
    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.



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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03116737


Locations
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United States, Oregon
Cyn3rgy Research
Gresham, Oregon, United States, 89104
Sponsors and Collaborators
Lachlan Pharma Holdings
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Responsible Party: Lachlan Pharma Holdings
ClinicalTrials.gov Identifier: NCT03116737    
Other Study ID Numbers: LP7700
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lachlan Pharma Holdings:
AOM
Additional relevant MeSH terms:
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Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Benzocaine
Pharmaceutical Solutions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents