Trial | NCT01084525  Report issue

Title

OTO-104 for Meniere's Disease
A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 1B Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    urea ...

  • Study Participants

    44
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.
Meniere's disease is a debilitating disorder of the inner ear which includes symptoms such as vertigo, tinnitus, hearing loss and aural fullness. Meniere's disease may result from an imbalance of fluid in the inner ear. Several studies have shown that corticosteroids may help manage this imbalance yet the effect does not last very long. OTO-104 is a longer lasting corticosteroid which could provide significant benefit to patients with Meniere's disease.
Study Started
Mar 31
2010
Primary Completion
Mar 31
2011
Study Completion
Apr 30
2011
Last Update
Jun 08
2011
Estimate

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.

OTO-104 (steroid) 3 mg Experimental

Placebo Placebo Comparator

OTO-104 (steroid) 12 mg Experimental

The start of 12 mg dose cohort is contingent on safety data from 3 mg dose cohort.

Criteria 

Inclusion Criteria:

Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
Subject has experienced active vertigo during the lead-in period.
Subject has asymmetric low frequency sensorineural hearing loss.
Subject agrees to maintain their current treatments for Meniere's disease while on-study.
Subjects not currently on a low-salt diet or diuretic should have a medical history of having used one or both of these treatments for at least 1 month without relief of symptoms.
Subjects currently on a low-salt diet and/or diuretic at the time of screening agree to continue this treatment throughout the study.

Exclusion Criteria:

Subject has an infection in the ear, sinuses, or upper respiratory system.
Subject is pregnant or lactating.
Subject has a history of immunodeficiency disease.
Subject has a history of previous endolymphatic sac surgery.
Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
Subject has experienced an adverse reaction to IT injection of steroids.
Subject has used an investigational drug or device in the 3 months prior to screening.
Subject has had a duration of Meniere's disease of >20 years.
No Results Posted