Phase 3 Study of OTO-201 in Acute Otitis Externa

Overview

This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).

Full Title of Study: “A Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, Phase 3 Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Externa”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: November 2016

Interventions

  • Drug: 12 mg ciprofloxacin
    • Single administration of OTO-201
  • Drug: Sham Control
    • Simulated, single adminstration

Arms, Groups and Cohorts

  • Experimental: OTO-201
  • Sham Comparator: Control

Clinical Trial Outcome Measures

Primary Measures

  • Number of Subjects Considered a Clinical Cure at Day 8
    • Time Frame: At Day 8 (1 week after dosing)
    • Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3

Secondary Measures

  • Number of Subjects Considered a Clinical Cure at Day 15
    • Time Frame: At Day 15 (2 weeks after dosing)
    • Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3

Participating in This Clinical Trial

Inclusion Criteria includes, but is not limited to:

  • Subject is a male or female age 6 months or older – Subject has a clinical diagnosis of unilateral or bilateral acute otitis externa – Subject or subject's caregiver is willing to comply with the protocol and attend all study visits Exclusion Criteria includes, but is not limited to: – Subject has tympanic membrane perforation – Subject has eczematoid otitis externa – Subject has diabetes mellitus

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Otonomy, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Carl LeBel, PhD, Study Chair, Otonomy, Inc.

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