Meniere's Disease Clinical Trial
Official title:
A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2b Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
Status | Completed |
Enrollment | 154 |
Est. completion date | April 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 documented asymmetric sensorineural hearing loss. - Subject agrees to maintain their current treatments for Meniere's disease while on-study. - 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 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 previously been randomized to a trial of OTO-104. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UC Health Otolaryngology - Head and Neck Surgery | Cincinnati | Ohio |
United States | Many sites in US and Canada. Refer to the contact info listed below. | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Otonomy, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease | 4 months | No | |
Secondary | Evaluation of adverse events, otoscopic exams, audiometry, Word Recognition Score and tympanometry as a measure of safety and tolerability | 4 months | Yes | |
Secondary | Evaluation of tinnitus patient reported questionnaire and daily diary as a measure of impact of tinnitus on activities of daily living | 4 months | No | |
Secondary | Evaluation of patient reported questionnaires as a measure of impact on patient daily activities | 4 months | No |
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