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Dose Ranging Study of OTO-201 in AOMT

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ClinicalTrials.gov Identifier: NCT02719158
Recruitment Status : Completed
First Posted : March 25, 2016
Results First Posted : September 24, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.

Study Description
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Brief Summary:
Dose Ranging Study of OTO-201 in AOMT

Condition or disease Intervention/treatment Phase
Acute Otitis Media AOMT Drug: 6 mg ciprofloxacin Drug: 12 mg ciprofloxacin Other: Sham Phase 2

Detailed 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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
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
Study Start Date : February 2016
Actual Primary Completion Date : June 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: 6 mg OTO-201
6 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.1 mL supra-tympanostomy tube (STT) administration to the affected ear(s)
 Drug: 6 mg ciprofloxacin
Single administration of OTO-201
Other Name: OTIPRIO
Experimental: 12 mg OTO-201
12 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.2 mL supra-tympanostomy tube (STT) administration to the affected ear(s)
 Drug: 12 mg ciprofloxacin
Single administration of OTO-201
Other Name: OTIPRIO
Sham Comparator: Sham (empty syringe)
Sham (empty syringe), single 0.1 mL STT administration to the affected ear(s)
 Other: Sham


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects With Adverse Events [ Time Frame: Up to 1 month ]
    Number of subjects with adverse events during the study from dosing up to 1 month after dosing

  2. Otoscopic Examination: Auricle and Meatus [ Time Frame: Up to 1 month ]
    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).

  3. Otoscopic Examination: Tympanic Membrane [ Time Frame: Up to 1 month ]
    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).


Secondary Outcome Measures :
  1. Absence of Otorrhea [ Time Frame: Up to Two Weeks ]
    Absence of otorrhea (middle ear drainage)


Eligibility Criteria
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Information from the National Library of Medicine

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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 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
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): NCT02719158


Locations
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United States, California
Contact Otonomy call center for trial locations
San Diego, California, United States, 92121
Sponsors and Collaborators
Otonomy, Inc.
Investigators
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Study Chair: Carl LeBel, PhD Otonomy, Inc.
More Information
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Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT02719158    
Other Study ID Numbers: 201-201508
First Posted: March 25, 2016    Key Record Dates
Results First Posted: September 24, 2020
Last Update Posted: October 19, 2020
Last Verified: September 2020
Keywords provided by Otonomy, Inc.:
Acute otitis media with tympanostomy tubes
OTIPRIO
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