OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tub… (NCT01949142) | Clinical Trial Compass
CompletedPhase 3
OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
United States266 participantsStarted 2013-11
Plain-language summary
The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
Who can participate
Age range
6 Months – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria includes, but is not limited to:
* Subject is a male or female aged 6 months to 17 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this was a Phase 3 trial for OTO-201 in children needing tympanostomy tubes, has this treatment been reviewed or approved by the FDA based on its results, and would it be an option my child's doctor could actually prescribe today?
2The trial measured 'treatment failures' as its main outcome — can you explain what counted as a treatment failure in this study, and what the results suggest about how well OTO-201 worked compared to whatever the children in the control group received?
3My child has been diagnosed with otitis media with effusion and may need tympanostomy tubes — based on what this trial found, does the evidence support using OTO-201 around the time of tube placement, or is standard care after surgery still the better-proven path?
4Since this study enrolled pediatric patients specifically, are there any age or health-related factors about my child that would affect whether the results from this trial are relevant to their situation?
5Were there any safety concerns or side effects identified in this trial that I should weigh when thinking about whether OTO-201 might be appropriate for my child?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants Who Were Treatment Failures