Dose Ranging Study of OTO-201 in AOMT

Acute Otitis Media Clinical Trial

Official title:

A 1-Month, Prospective, Multicenter, Randomized, Dose-Ranging, Sham-Controlled, Blinded Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Media With Tympanostomy Tubes in Pediatric Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719158
• Other study ID #: 201-201508
• Status: Completed
• Phase: Phase 2
• Start date: February 2016
• Est. completion date: July 2016

Study information

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

Clinical Trial Summary

Dose Ranging Study of OTO-201 in AOMT

Description:

This is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled, blinded study in which eligible subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201, 12 mg OTO-201, or sham into the affected ear(s).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

Inclusion Criteria includes, but is not limited to:

• Subject is a male or female aged 6 months to 17 years, inclusive

• Subject has a clinical diagnosis of acute otitis media with tympanostomy tubes (AOMT)

• Subject's caregiver is willing to comply with the protocol an attend all study visits

Exclusion Criteria includes, but is not limited to:

• Subject has a history of sensorineural hearing loss

• Subject has tympanic membrane perforation other than the surgical tympanostomy tube perforation

• Subject has a history of known immunodeficiency disease

Related Conditions & MeSH terms

• Acute Otitis Media
• AOMT
• Otitis
• Otitis Media

Intervention

Drug:
• 6 mg ciprofloxacin
Single administration of OTO-201
• 12 mg ciprofloxacin
Single administration of OTO-201

Other:
• Sham

Locations

Country	Name	City	State
United States	Contact Otonomy call center for trial locations	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Otonomy, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Adverse Events	Number of subjects with adverse events during the study from dosing up to 1 month after dosing	Up to 1 month
Primary	Otoscopic Examination: Auricle and Meatus	Number of affected ears (i.e., those ears that were infected) whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The auricle and meatus of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the auricle and meatus with treatment (i.e., a safety measure).	Up to 1 month
Primary	Otoscopic Examination: Tympanic Membrane	Number of affected ears (i.e., those ears that were infected) whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The tympanic membrane of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the tympanic membrane with treatment (i.e., a safety measure).	Up to 1 month
Secondary	Absence of Otorrhea	Absence of otorrhea (middle ear drainage)	Up to Two Weeks