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

Otonomy

Status and phase: Completed; Phase 1

Conditions: Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement

Treatments: Drug: Sham; Drug: Placebo; Drug: OTO-201

Study type: Interventional

Funder types: Industry

Identifiers

NCT01755286

201-201101

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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83 participants in 4 patient groups, including a placebo group

4 mg OTO-201

Experimental group

Treatment:

Drug: OTO-201

12 mg OTO-201

Experimental group

Treatment:

Drug: OTO-201

Vehicle for OTO-201

Placebo Comparator group

Treatment:

Drug: Placebo

Sham

Sham Comparator group

Treatment:

Drug: Sham