Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes

Otitis Media Clinical Trial

Official title:

An 8-Week, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600559
• Other study ID #: 201-201507
• Status: Completed
• Phase: Phase 3
• Start date: October 2015
• 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

This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: July 2016
• Est. primary completion date: July 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 history of otitis media requiring bilateral tympanostomy tube placement

• 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 a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with TT placement

• Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, except adenoidectomy, airway endoscopy, nasal endoscopy, and nasal cautery for epistaxis

• Subject has a history of sensorineural hearing loss

Related Conditions & MeSH terms

• Otitis
• Otitis Media

Intervention

Drug:
• OTO-201 (ciprofloxacin)

Locations

Country	Name	City	State
United States	Email Otonomy Central Contact 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 Post-surgical Otorrhea	Absence or presence of otorrhea (drainage from the middle ear)	Week 4
Primary	Number of Subjects With Post-surgical Otorrhea	Absence or presence of otorrhea (drainage from the middle ear)	8 weeks
Secondary	Adverse Events	Evaluation of adverse events	Up to Eight Weeks
Secondary	Caregiver Burden - Ear Discharge Control	Ear Drop Caregiver Burden Questionnaire at Week 4	Week 4
Secondary	Caregiver Burden - Ear Discharge Control	Ear Drop Caregiver Burden Questionnaire at Week 8	Week 8
Secondary	Caregiver Burden - Ear Drops Administration	Ear Drop Caregiver Burden Questionnaire at Week 8	Week 8