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

Phase 1

Completed

• Conditions: Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement
• Interventions: Drug: OTO-201; Drug: Placebo; Drug: Sham

• Registration Number: NCT01755286
• Lead Sponsor: Otonomy, Inc.

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 available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-24
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
4 mg OTO-201	OTO-201	-
12 mg OTO-201	OTO-201	-
Vehicle for OTO-201	Placebo	-
Sham	Sham	-

Primary Outcome Measures

Name	Time	Method
Safety	Up to 1 month	Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry

Secondary Outcome Measures

Name	Time	Method
Clinical Activity	Up to 1 month	Evaluation of physician reported and caregiver reported otorrhea
Microbiological Eradication	Up to 1 month	Microbiological eradication of pretherapy bacteria

Trial Locations

Locations (1)

Call/Email Otonomy Central Contact for Trial Locations; 🇺🇸 San Diego, California, United States