Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01084525
Study type Interventional
Source Otonomy, Inc.
Contact
Status Completed
Phase Phase 1
Start date March 2010
Completion date April 2011

See also
  Status Clinical Trial Phase
Recruiting NCT06001593 - Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation Phase 1/Phase 2
Completed NCT03325790 - SPI-1005 for the Treatment of Patients With Meniere's Disease Phase 2
Completed NCT02612337 - Study of OTO-104 in Subjects With Unilateral Meniere's Disease Phase 3
Completed NCT02265393 - A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom Phase 2
Completed NCT02309099 - Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach N/A
Completed NCT01412177 - OTO-104 for the Treatment of Meniere's Disease Phase 2
Terminated NCT02717442 - Study of OTO-104 in Subjects With Unilateral Meniere's Disease Phase 3
Terminated NCT02530931 - Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease Phase 4
Terminated NCT02740387 - Open Label Study of OTO-104 in Subjects With Meniere's Disease Phase 2
Completed NCT02158585 - Study of Lamotrigine to Treat Ménière's Disease Phase 2
Completed NCT00145483 - Sildenafil For Meniere's Disease Phase 4
Suspended NCT04026516 - CAVA: Dizziness Trial N/A
Recruiting NCT03587701 - Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease Phase 2
Completed NCT02080312 - Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent N/A
Completed NCT01454726 - Clinical Trial of Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease Phase 3
Recruiting NCT01099046 - Stress Management Therapy for Meniere's Disease N/A
Completed NCT00160238 - Effects of Betaserc on Vestibular Compensation in Patients Suffering From Disabling Meniere's Disease and Having Undergone Vestibular Neurotomy Phase 4
Terminated NCT02706730 - A 6-Month Extension Study of OTO-104 in Meniere's Disease Phase 3
Completed NCT02718846 - Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets Phase 4
Completed NCT02603081 - Study to Evaluate SPI-1005 in Adults With Meniere's Disease Phase 1/Phase 2