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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02600559
Other study ID # 201-201507
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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