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NCT01755286 · ClinicalTrials.gov registry record · Phase 1
OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
A Phase 1 study of Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement, sponsored by Otonomy.
- Completed
- Registry status
- Phase 1
- Development phase
- 83
- Enrollment target
- 1
- Study location
NCT01755286: Completed Phase 1 study of Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement, sponsored by Otonomy.
NCT01755286 is a Phase 1 study of Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement that has completed, run by Otonomy. The registered enrollment target is 83 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01755286, a Phase 1 study of Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement, has completed, sponsored by Otonomy.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 83 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sham
- DRUG OTO-201
Study Locations (1)
California
- Call/Email Otonomy Central Contact for Trial Locations - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2012-12 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
What the finished NCT01755286 record still lists
NCT01755286 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% higher).
The record links to 1 condition, with Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01755286 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01755286 about?
NCT01755286 is a clinical study titled "OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement". 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.
What is the current status of trial NCT01755286?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2012-12. Estimated completion is 2013-06.
What conditions does trial NCT01755286 study?
This clinical trial studies the following conditions: Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement.
What interventions are being tested in trial NCT01755286?
The interventions under investigation include: Placebo (DRUG), Sham (DRUG), OTO-201 (DRUG).
Who is sponsoring clinical trial NCT01755286?
This trial is sponsored by Otonomy, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01755286 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01755286's enrollment target sits among peer trials
83 665th of 2000 higher than 1,332 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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