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History of Changes for Study: NCT01755286
OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
Latest version (submitted June 17, 2013) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 18, 2012 None (earliest Version on record)
2 June 17, 2013 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

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Study NCT01755286
Submitted Date:  December 18, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: 201-201101
Brief Title: OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
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
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2012
Overall Status: Recruiting
Study Start: December 2012
Primary Completion: July 2013 [Anticipated]
Study Completion: August 2013 [Anticipated]
First Submitted: December 18, 2012
First Submitted that
Met QC Criteria:
December 18, 2012
First Posted: December 24, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 18, 2012
Last Update Posted: December 24, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Otonomy, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 4
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Allocation: Randomized
Enrollment: 80 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: 4 mg OTO-201 Drug: OTO-201
Single intra-operative injection
Other Names:
  • ciprofloxacin
Experimental: 12 mg OTO-201 Drug: OTO-201
Single intra-operative injection
Other Names:
  • ciprofloxacin
Placebo Comparator: Vehicle for OTO-201 Drug: Placebo
Single intratympanic injection
Sham Comparator: Sham Drug: Sham
Simulated single intratympanic injection
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 6 Months
Maximum Age: 12 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Liza Wallace
Telephone: 858-242-5200
Email: LWallace@Otonomy.com
Study Officials: Carl LeBel, PhD
Study Chair
Otonomy, Inc.
Locations: United States, California
Call/Email Otonomy Central Contact for Trial Locations
[Recruiting]
San Diego, California, United States, 92121
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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