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OpenTrials
Completed

NCT Number: NCT01755286

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

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.

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Key information

Conditions

Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Call/Email Otonomy Central Contact for Trial Locations

San Diego, California, 92121, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OTO-201

Drug

Single intra-operative injection

Other names: ciprofloxacin

Placebo

Drug

Single intratympanic injection

sham

Drug

Simulated single intratympanic injection

Primary outcomes

  1. Safety

    Time frame: Up to 1 month

    Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Otonomy, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 24, 2012
Registry last updated
Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.