OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
This study has been completed.
Sponsor:
Otonomy, Inc.
ClinicalTrials.gov Identifier:
NCT01755286
First Posted: December 24, 2012
Last Update Posted: June 19, 2013
Information provided by (Responsible Party):
Otonomy, Inc.
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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 Intervention Model: Single Group Assignment Masking: Triple (Participant, Care Provider, 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:
Further study details as provided by Otonomy, Inc.:
Primary Outcome Measures:
- Safety [ Time Frame: Up to 1 month ]Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry
Secondary Outcome Measures:
- Clinical Activity [ Time Frame: Up to 1 month ]Evaluation of physician reported and caregiver reported otorrhea
- Microbiological Eradication [ Time Frame: Up to 1 month ]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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 6 Months to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| First Submitted: | December 18, 2012 |
| First Posted: | December 24, 2012 |
| Last Update Posted: | June 19, 2013 |
| Last Verified: | June 2013 |
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 |