Meniere's Disease Clinical Trial
Official title:
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
Verified date | June 2011 |
Source | Otonomy, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | April 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. 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. 2. Subject has experienced active vertigo during the lead-in period. 3. Subject has asymmetric low frequency sensorineural hearing loss. 4. Subject agrees to maintain their current treatments for Meniere's disease while on-study. 5. 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. 6. 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: 1. Subject has an infection in the ear, sinuses, or upper respiratory system. 2. Subject is pregnant or lactating. 3. Subject has a history of immunodeficiency disease. 4. Subject has a history of previous endolymphatic sac surgery. 5. Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear. 6. Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure. 7. Subject has experienced an adverse reaction to IT injection of steroids. 8. Subject has used an investigational drug or device in the 3 months prior to screening. 9. Subject has had a duration of Meniere's disease of >20 years. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Hospitals, Dept. of Otolaryngology | Ann Arbor | Michigan |
United States | Mass Eye & Ear Infirmary | Boston | Massachusetts |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Northwestern University, Feinberg School of Medicine, Otolaryngology | Chicago | Illinois |
United States | Colorado Otolaryngology Associates | Colorado Springs | Colorado |
United States | University Of Texas, Southwestern Medical Center | Dallas | Texas |
United States | Michigan Ear Institute | Farmington Hills | Michigan |
United States | House Ear Institute | Los Angeles | California |
United States | New York Eye and Ear Infirmary | New York | New York |
United States | Crescent Medical Research | Salisbury | North Carolina |
United States | University of California, San Diego | San Diego | California |
United States | Silverstein Institute | Sarasota | Florida |
United States | St Louis University | St Louis | Missouri |
United States | Wilmington Medical Research | Wilmington | North Carolina |
United States | Piedmont Medical Research | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Otonomy, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary objective of this study is to evaluate the safety and tolerability of two ascending OTO-104 doses relative to placebo. Safety assessments will be performed for 3 months post single intratympanic injection of OTO-104 or placebo. | 3 months | Yes | |
Secondary | The secondary objective of this study is to evaluate the clinical activity of two OTO-104 doses relative to placebo. Change in baseline for vertigo frequency will be evaluated with descriptive statistics. | 3 months | No | |
Secondary | The impact of tinnitus on activities of daily living will be measured. | 3 months | No | |
Secondary | Hearing loss in the affected ear will be measured by audiometric examination. | 3 months | No | |
Secondary | Quality of life will be measured by patient reported questionnaire. | 3 months | No | |
Secondary | Severity of vertigo episodes will be measured by the patient reported vertigo score. | 3 months | No |
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