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4 mg OTO-201 for Ear Tube Insertion

Phase 1
Waitlist Available
Research Sponsored by Otonomy, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 month
Awards & highlights
All Individual Drugs Already Approved
Approved for 40 Other Conditions

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.

Eligible Conditions
  • Ear Tube Insertion

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety
Secondary study objectives
Clinical Activity
Microbiological Eradication

Side effects data

From 2014 Phase 3 trial • 266 Patients • NCT01949142
8%
Pyrexia
7%
Nasopharyngitis
6%
Irritability
6%
Upper respiratory tract infection
6%
Teething
3%
Cough
1%
Bronchiolitis
1%
Gastroenteritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
OTO-201 Single, Intratympanic Injection
Sham-Simulated Single, Intratympanic Injection

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 40 Other Conditions
This treatment demonstrated efficacy for 40 other conditions.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: 4 mg OTO-201Experimental Treatment1 Intervention
Group II: 12 mg OTO-201Experimental Treatment1 Intervention
Group III: Vehicle for OTO-201Placebo Group1 Intervention
Group IV: ShamPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ciprofloxacin
FDA approved

Find a Location

Who is running the clinical trial?

Otonomy, Inc.Lead Sponsor
21 Previous Clinical Trials
2,996 Total Patients Enrolled
Carl LeBel, PhDStudy ChairOtonomy, Inc.
15 Previous Clinical Trials
1,666 Total Patients Enrolled
~6 spots leftby Dec 2025
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