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Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration

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: NCT02350998
Recruitment Status : Completed
First Posted : January 30, 2015
Results First Posted : September 23, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.

Tracking Information
First Submitted Date  ICMJE January 21, 2015
First Posted Date  ICMJE January 30, 2015
Results First Submitted Date  ICMJE September 1, 2020
Results First Posted Date  ICMJE September 23, 2020
Last Update Posted Date October 19, 2020
Study Start Date  ICMJE January 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2020)
  • Otoscopic Examination: Auricle and Meatus [ Time Frame: Up to 1 month ]
    Number of ears whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29
  • Otoscopic Examination: Tympanic Membrane [ Time Frame: up to 1 month ]
    Number of ears whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29
  • Otoscopic Examination: Tube Patency [ Time Frame: Up to 1 month ]
    Subjects with at least one ear tube patent (i.e., not blocked) at Day 29
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2015)
Safety: Adverse events, otoscopic exams and tympanometry [ Time Frame: Up to 1 month ]
Evaluation of adverse events, otoscopic exams and tympanometry
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2020)
Feasibility of Administration [ Time Frame: Day 1 ]
Ease of administering OTO-201 through the tympanostomy tube: Number of subjects that investigators rated ease of administration as either "easy" or "very easy"
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2015)
Feasibility of Administration (Questionnaire on the feasibility of trans-tympanostomy tube administration) [ Time Frame: Day 1 ]
Questionnaire on the feasibility of trans-tympanostomy tube administration
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
Official Title  ICMJE A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Trans-Tympanic Tube Administration for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects With Otitis Media Requiring Tympanostomy Tube Placement
Brief Summary This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The study is designed to characterize safety and any procedural issues associated with TTT drug administration of OTO-201.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bilateral Middle Ear Effusion
Intervention  ICMJE Drug: OTO-201
Study Arms  ICMJE Experimental: OTO-201
6 mg OTO-201 administered trans-tympanostomy tube
Intervention: Drug: OTO-201
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: March 9, 2015)
33
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2015)
30
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (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 17 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 an 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 been designated for any other surgical procedure that would occur concurrently with TT placement, such as, but not limited to adenoidectomy or tonsillectomy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 17 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 NCT02350998
Other Study ID Numbers  ICMJE 201-201404
Has Data Monitoring Committee No
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 September 2020

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