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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.

Tracking Information
First Submitted Date  ICMJE December 18, 2012
First Posted Date  ICMJE December 24, 2012
Last Update Posted Date June 19, 2013
Study Start Date  ICMJE December 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
Safety [ Time Frame: Up to 1 month ]
Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
  • Clinical Activity [ Time Frame: Up to 1 month ]
    Evaluation of physician reported and caregiver reported otorrhea
  • Microbiological Eradication [ Time Frame: Up to 1 month ]
    Microbiological eradication of pretherapy bacteria
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
Official Title  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement
Intervention  ICMJE
  • Drug: OTO-201
    Single intra-operative injection
    Other Name: ciprofloxacin
  • Drug: Placebo
    Single intratympanic injection
  • Drug: Sham
    Simulated single intratympanic injection
Study Arms  ICMJE
  • Experimental: 4 mg OTO-201
    Intervention: Drug: OTO-201
  • Experimental: 12 mg OTO-201
    Intervention: Drug: OTO-201
  • Placebo Comparator: Vehicle for OTO-201
    Intervention: Drug: Placebo
  • Sham Comparator: Sham
    Intervention: Drug: Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2013)
83
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2012)
80
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01755286
Other Study ID Numbers  ICMJE 201-201101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Otonomy, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Otonomy, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Carl LeBel, PhD Otonomy, Inc.
PRS Account Otonomy, Inc.
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP