OTO-104 for the Treatment of Meniere's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01412177|
Recruitment Status : Completed
First Posted : August 9, 2011
Last Update Posted : September 3, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Meniere's Disease||Drug: OTO-104 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||April 2015|
Single intratympanic injection of 12 mg OTO-104
|Placebo Comparator: Placebo||
Single intratympanic injection of placebo
- Reduction in vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease [ Time Frame: 4 months ]
- Evaluation of adverse events, otoscopic exams, audiometry, Word Recognition Score and tympanometry as a measure of safety and tolerability [ Time Frame: 4 months ]
- Evaluation of tinnitus patient reported questionnaire and daily diary as a measure of impact of tinnitus on activities of daily living [ Time Frame: 4 months ]
- Evaluation of patient reported questionnaires as a measure of impact on patient daily activities [ Time Frame: 4 months ]
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412177
|United States, California|
|Many sites in US and Canada. Refer to the contact info listed below.|
|San Diego, California, United States|
|United States, Ohio|
|UC Health Otolaryngology - Head and Neck Surgery|
|Cincinnati, Ohio, United States, 45219|
|Study Chair:||Carl LeBel, PhD||Otonomy, Inc.|
|Responsible Party:||Otonomy, Inc.|
|Other Study ID Numbers:||
|First Posted:||August 9, 2011 Key Record Dates|
|Last Update Posted:||September 3, 2015|
|Last Verified:||August 2015|