- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02600559
Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
September 21, 2020 updated by: Otonomy, Inc.
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
501
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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San Diego, California, United States, 92121
- Email Otonomy Central Contact for Trial Locations
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 0.1 mL OTO-201
Ciprofloxacin
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Post-surgical Otorrhea
Time Frame: Week 4
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Absence or presence of otorrhea (drainage from the middle ear)
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Week 4
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Number of Subjects With Post-surgical Otorrhea
Time Frame: 8 weeks
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Absence or presence of otorrhea (drainage from the middle ear)
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8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: Up to Eight Weeks
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Evaluation of adverse events
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Up to Eight Weeks
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Caregiver Burden - Ear Discharge Control
Time Frame: Week 4
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Ear Drop Caregiver Burden Questionnaire at Week 4
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Week 4
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Caregiver Burden - Ear Discharge Control
Time Frame: Week 8
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Ear Drop Caregiver Burden Questionnaire at Week 8
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Week 8
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Caregiver Burden - Ear Drops Administration
Time Frame: Week 8
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Ear Drop Caregiver Burden Questionnaire at Week 8
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Week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Dean Hakanson, MD, Otonomy, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (ACTUAL)
July 1, 2016
Study Completion (ACTUAL)
July 1, 2016
Study Registration Dates
First Submitted
November 5, 2015
First Submitted That Met QC Criteria
November 5, 2015
First Posted (ESTIMATE)
November 9, 2015
Study Record Updates
Last Update Posted (ACTUAL)
October 19, 2020
Last Update Submitted That Met QC Criteria
September 21, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Otorhinolaryngologic Diseases
- Ear Diseases
- Otitis
- Otitis Media
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 CYP1A2 Inhibitors
- Ciprofloxacin
Other Study ID Numbers
- 201-201507
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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