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OTO-104 for Meniere's Disease

NCT01084525 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2011-06-08

No results posted yet for this 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.

Conditions

  • Meniere's Disease

Interventions

DRUG

OTO-104 (steroid) 3 mg

OTO-104 3 mg dose cohort, single intratympanic injection.

DRUG

Placebo

Placebo arm will be conducted in parallel with each OTO-104 dose cohort.

DRUG

OTO-104 (steroid) 12 mg

Sequential dose cohort escalation to OTO-104 12 mg dose cohort will occur pending the safety evaluation of 28 day follow up safety data for the OTO-104 3 mg dose cohort. OTO-104 12mg dose cohort is also a single intratympanic injection.

Sponsors & Collaborators

  • Otonomy, Inc.

    lead INDUSTRY

Principal Investigators

  • Carl LeBel, PhD · Otonomy, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-03-31
Completion
2011-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01084525 on ClinicalTrials.gov