Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01949155 · ClinicalTrials.gov registry record · Phase 3
OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
A Phase 3 study, sponsored by Otonomy.
- Completed
- Registry status
- Phase 3
- Development phase
- 266
- Enrollment target
NCT01949155: Completed Phase 3 study, sponsored by Otonomy.
NCT01949155 is a Phase 3 study that has completed, run by Otonomy. The registered enrollment target is 266 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01949155, a Phase 3 study, has completed, sponsored by Otonomy.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 266 participants
- Enrollment target
Study 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.
Primary Outcome
Cumulative proportion of treatment failures: The efficacy endpoint for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up.
Interventions
- DRUG Sham
- DRUG OTO-201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 266 participants |
| Start Date | 2013-11 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
What the finished NCT01949155 record still lists
NCT01949155 is an interventional study that assigns participants to a tested intervention. The registered 266 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham is the first listed.
NCT01949155 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01949155 about?
NCT01949155 is a clinical study titled "OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement". 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.
What is the current status of trial NCT01949155?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 266 participants. The study started on 2013-11. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01949155?
The interventions under investigation include: Sham (DRUG), OTO-201 (DRUG).
Who is sponsoring clinical trial NCT01949155?
This trial is sponsored by Otonomy, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01949155's enrollment target sits among peer trials
266 1222nd of 2000 higher than 778 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05098652 · 266 participants · NA
Coaching Dementia Caregivers to Master Care-Resistant Behavior
- NCT06088277 · 266 participants · NA
Texting to Reduce Human Immunodeficiency Virus (HIV) Risk
- NCT06261814 · 266 participants · Phase 2
Contrast Enhanced Ultrasound to Evaluate Response to Chemoembolization in Patients With Liver Tumors
- NCT06312124 · 266 participants · NA
A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia