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NCT01084525 · ClinicalTrials.gov registry record · Phase 1

OTO-104 for Meniere's Disease

A Phase 1 study, sponsored by Otonomy.

Completed
Registry status
Phase 1
Development phase
44
Enrollment target

NCT01084525: Completed Phase 1 study, sponsored by Otonomy.

NCT01084525 is a Phase 1 study that has completed, run by Otonomy. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01084525, a Phase 1 study, has completed, sponsored by Otonomy.

COMPLETED
Registry status
Phase 1
Development phase
44 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety of OTO-104 in subjects with unilateral Meniere's disease. The effectiveness of OTO-104 to reduce the symptoms of Meniere's disease will also be evaluated.

Interventions

  • DRUG Placebo
  • DRUG OTO-104 (steroid) 3 mg
  • DRUG OTO-104 (steroid) 12 mg

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2010-03
Est. Completion 2011-04
Phase Phase 1
Otonomy

20 total trials

What the finished NCT01084525 record still lists

NCT01084525 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01084525 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01084525 about?

NCT01084525 is a clinical study titled "OTO-104 for Meniere's Disease". The purpose of this study is to evaluate the safety of OTO-104 in subjects with unilateral Meniere's disease. The effectiveness of OTO-104 to reduce the symptoms of Meniere's disease will also be evaluated.

What is the current status of trial NCT01084525?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2010-03. Estimated completion is 2011-04.

What interventions are being tested in trial NCT01084525?

The interventions under investigation include: Placebo (DRUG), OTO-104 (steroid) 3 mg (DRUG), OTO-104 (steroid) 12 mg (DRUG).

Who is sponsoring clinical trial NCT01084525?

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

How this trial's enrollment target compares

Where NCT01084525's enrollment target sits among peer trials

44 1086th of 2000 higher than 901 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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Source: ClinicalTrials.gov NCT01084525, the US trial registry maintained by the National Library of Medicine. NCT01084525 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.