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

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ClinicalTrials.gov Identifier: NCT02600559
Recruitment Status : Completed
First Posted : November 9, 2015
Results First Posted : September 22, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Otitis Media Drug: OTO-201 (ciprofloxacin) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 501 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arms and Interventions
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Arm Intervention/treatment
Experimental: 0.1 mL OTO-201
Ciprofloxacin
 Drug: OTO-201 (ciprofloxacin)
Other Name: OTIPRIO


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects With Post-surgical Otorrhea [ Time Frame: Week 4 ]
    Absence or presence of otorrhea (drainage from the middle ear)

  2. Number of Subjects With Post-surgical Otorrhea [ Time Frame: 8 weeks ]
    Absence or presence of otorrhea (drainage from the middle ear)


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to Eight Weeks ]
    Evaluation of adverse events

  2. Caregiver Burden - Ear Discharge Control [ Time Frame: Week 4 ]
    Ear Drop Caregiver Burden Questionnaire at Week 4

  3. Caregiver Burden - Ear Discharge Control [ Time Frame: Week 8 ]
    Ear Drop Caregiver Burden Questionnaire at Week 8

  4. Caregiver Burden - Ear Drops Administration [ Time Frame: Week 8 ]
    Ear Drop Caregiver Burden Questionnaire at Week 8


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600559


Locations
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United States, California
Email Otonomy Central Contact for Trial Locations
San Diego, California, United States, 92121
Sponsors and Collaborators
Otonomy, Inc.
Investigators
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Study Chair: Dean Hakanson, MD Otonomy, Inc.
More Information
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Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT02600559    
Other Study ID Numbers: 201-201507
First Posted: November 9, 2015    Key Record Dates
Results First Posted: September 22, 2020
Last Update Posted: October 19, 2020
Last Verified: September 2020
Keywords provided by Otonomy, Inc.:
Otitis media
Ear infection
Tympanostomy tubes
Additional relevant MeSH terms:
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Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
 Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors