OTO-104 for the Treatment of Meniere's Disease
This study is not yet open for participant recruitment.
Verified September 2012 by Otonomy, Inc.
Information provided by (Responsible Party):
First received: July 31, 2011
Last updated: September 10, 2012
Last verified: September 2012
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Otonomy, Inc.:
Primary Outcome Measures:
- Reduction in vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluation of adverse events, otoscopic exams, audiometry, Word Recognition Score and tympanometry as a measure of safety and tolerability [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- Evaluation of patient reported questionnaires as a measure of impact on patient daily activities [ Time Frame: 4 months ] [ Designated as safety issue: No ]
|Experimental: OTO-104 (steroid) 12 mg||
Single intratympanic injection of 12 mg OTO-104.
|Placebo Comparator: Vehicle for OTO-104||
Single intratympanic injection of placebo
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412177
|Contact: Carl LeBel, PhD||(858) 242-5213||CLeBel@Otonomy.com|
Sponsors and Collaborators
|Study Chair:||Carl LeBel, PhD||Otonomy, Inc.|