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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.
ClinicalTrials.gov Identifier:
NCT01755286
First received: December 18, 2012
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement
Drug: OTO-201
Drug: Placebo
Drug: Sham
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Otonomy, Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: Up to 1 month ] [ Designated as safety issue: Yes ]
    Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry


Secondary Outcome Measures:
  • Clinical Activity [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
    Evaluation of physician reported and caregiver reported otorrhea

  • Microbiological Eradication [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
    Microbiological eradication of pretherapy bacteria


Enrollment: 83
Study Start Date: December 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Months to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755286

Locations
United States, California
Call/Email Otonomy Central Contact for Trial Locations
San Diego, California, United States, 92121
Sponsors and Collaborators
Otonomy, Inc.
Investigators
Study Chair: Carl LeBel, PhD Otonomy, Inc.
  More Information

No publications provided

Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT01755286     History of Changes
Other Study ID Numbers: 201-201101
Study First Received: December 18, 2012
Last Updated: June 17, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Otitis Media with Effusion
Ear Diseases
Otitis
Otitis Media
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014