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

Purpose

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.

Condition	Intervention	Phase
Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement	Drug: OTO-201 Drug: Placebo Drug: Sham	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Drug Information available for: Ciprofloxacin

U.S. FDA Resources

Further study details as provided by Otonomy, Inc.:

Primary Outcome Measures:

Safety [ Time Frame: Up to 1 month ] [ Designated as safety issue: Yes ]
Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry

Secondary Outcome Measures:

Clinical Activity [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
Evaluation of physician reported and caregiver reported otorrhea
Microbiological Eradication [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
Microbiological eradication of pretherapy bacteria


Enrollment:	83
Study Start Date:	December 2012
Study Completion Date:	June 2013
Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 4 mg OTO-201	Drug: OTO-201 Single intra-operative injection Other Name: ciprofloxacin
Experimental: 12 mg OTO-201	Drug: OTO-201 Single intra-operative injection Other Name: ciprofloxacin
Placebo Comparator: Vehicle for OTO-201	Drug: Placebo Single intratympanic injection
Sham Comparator: Sham	Drug: Sham Simulated single intratympanic injection

Eligibility


Ages Eligible for Study:	6 Months to 12 Years (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755286

Locations


United States, California
Call/Email Otonomy Central Contact for Trial Locations
San Diego, California, United States, 92121

Sponsors and Collaborators

Otonomy, Inc.

Investigators


Study Chair:	Carl LeBel, PhD	Otonomy, Inc.

More Information


Responsible Party:	Otonomy, Inc.
ClinicalTrials.gov Identifier:	NCT01755286 History of Changes
Other Study ID Numbers:	201-201101
Study First Received:	December 18, 2012
Last Updated:	June 17, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Otitis Media with Effusion Otitis Media Otitis Ear Diseases Otorhinolaryngologic Diseases Ciprofloxacin Anti-Bacterial Agents Anti-Infective Agents	Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2016