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OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01755286
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.

Study Description
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Brief Summary:
The purpose of this study is to describe the safety and tolerability of two dose levels of OTO-201, placebo and sham when administered intra-operatively in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.

Condition or disease Intervention/treatment Phase
Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement Drug: OTO-201 Drug: Placebo Drug: Sham Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind, Placebo- and Sham-Controlled, Multicenter, Phase 1b Study of OTO-201 Given as a Single Intratympanic Injection for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
Study Start Date : December 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 4 mg OTO-201 Drug: OTO-201
Single intra-operative injection
Other Name: ciprofloxacin
Experimental: 12 mg OTO-201 Drug: OTO-201
Single intra-operative injection
Other Name: ciprofloxacin
Placebo Comparator: Vehicle for OTO-201 Drug: Placebo
Single intratympanic injection
Sham Comparator: Sham Drug: Sham
Simulated single intratympanic injection


Outcome Measures
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Primary Outcome Measures :
  1. Safety [ Time Frame: Up to 1 month ]
    Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry


Secondary Outcome Measures :
  1. Clinical Activity [ Time Frame: Up to 1 month ]
    Evaluation of physician reported and caregiver reported otorrhea

  2. Microbiological Eradication [ Time Frame: Up to 1 month ]
    Microbiological eradication of pretherapy bacteria


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 12 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 12 years, inclusive
  • Subject has a clinical diagnosis of bilateral middle ear effusion requiring 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 tympanostomy tube placement
  • Subject has a history of sensorineural hearing loss
  • Subject has a history of chronic or recurrent bacterial infections other than otitis media that likely will require treatment with antibiotics during the course of the study
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): NCT01755286


Locations
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United States, California
Call/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: Carl LeBel, PhD Otonomy, Inc.
More Information
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Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT01755286    
Other Study ID Numbers: 201-201101
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Otitis Media with Effusion
Otitis Media
Otitis
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