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NCT02408796 · ClinicalTrials.gov registry record · Phase 2

Open-Label Study of OTO-201 for Treatment of AOMT

A Phase 2 study, sponsored by Otonomy.

Completed
Registry status
Phase 2
Development phase
39
Enrollment target

NCT02408796 is a Phase 2 study that has completed, run by Otonomy. The registered enrollment target is 39 participants.

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The verdict

NCT02408796, a Phase 2 study, has completed, sponsored by Otonomy.

COMPLETED
Registry status
Phase 2
Development phase
39 participants
Enrollment target

Study Summary

This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with AOMT.

Interventions

  • DRUG OTO-201

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2015-03
Est. Completion 2015-05
Phase Phase 2

Sponsor

Otonomy

20 total trials

What the Registry Record Tells You About NCT02408796

The ClinicalTrials.gov registry entry for NCT02408796 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otonomy, which has 20 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which OTO-201 is the first listed.

NCT02408796 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02408796 about?

NCT02408796 is a clinical study titled "Open-Label Study of OTO-201 for Treatment of AOMT". This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is designed to characterize safety...

What is the current status of trial NCT02408796?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2015-03. Estimated completion is 2015-05.

What interventions are being tested in trial NCT02408796?

The interventions under investigation include: OTO-201 (DRUG).

Who is sponsoring clinical trial NCT02408796?

This trial is sponsored by Otonomy, which has 20 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.