Phase 3 Study of OTO-201 in Acute Otitis Externa

Acute Otitis Externa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02801370
• Other study ID #: 201-201609
• Status: Completed
• Phase: Phase 3
• Start date: June 2016
• Est. completion date: December 2016

Study information

• Verified date: September 2020
• Source: Otonomy, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Otitis Externa
• Otitis
• Otitis Externa
• Swimmer's Ear

Intervention

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

Locations

Country	Name	City	State
Canada	Call Otonomy call center for trial locations	Saskatoon
United States	Call Otonomy call center for trial locations	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Otonomy, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Considered a Clinical Cure at Day 8	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	At Day 8 (1 week after dosing)
Secondary	Number of Subjects Considered a Clinical Cure at Day 15	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	At Day 15 (2 weeks after dosing)