OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01755286 |
Recruitment Status :
Completed
First Posted : December 24, 2012
Last Update Posted : June 19, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement | Drug: OTO-201 Drug: Placebo Drug: Sham | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 83 participants |
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 |
Study Start Date : | December 2012 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
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 |
- Safety [ Time Frame: Up to 1 month ]Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry
- 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

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Ages Eligible for Study: | 6 Months to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, California | |
Call/Email Otonomy Central Contact for Trial Locations | |
San Diego, California, United States, 92121 |
Study Chair: | Carl LeBel, PhD | Otonomy, Inc. |
Responsible Party: | Otonomy, Inc. |
ClinicalTrials.gov Identifier: | NCT01755286 |
Other Study ID Numbers: |
201-201101 |
First Posted: | December 24, 2012 Key Record Dates |
Last Update Posted: | June 19, 2013 |
Last Verified: | June 2013 |
Otitis Media with Effusion Otitis Media Otitis Ear Diseases Otorhinolaryngologic Diseases Ciprofloxacin Anti-Bacterial Agents Anti-Infective Agents |
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