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A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER, PHASE 3 EFFICACY AND SAFETY STUDY OF OTO-104 GIVEN AS A SINGLE INTRATYMPANIC INJECTION IN SUBJECTS WITH UNILATERAL MENIERE'S DISEASE

Study category: Ear, Nose, and Throat

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Description

Participants will come into the clinic for 5 visits which will last 1. 5-3.5 hours long. Each visit has an Audiologist and an Otologist component in it. Each participant will need to complete daily diary entries by calling into phone number and answering some questions.

Details
Age

Adult

Eligibility

These are some of the inclusion/exclusion criteria, others do apply. Inclusion: 1. Male or Female aged 18-75 years 2. Diagnosis of definite unilateral Meniere's disease 3. Female participants, not Pregnant or lactating 4. Willing to comply with comply with the study visits 5. Able to use the telephone for a daily diary for the entire study Exclusion: 1. History of immunodeficiency disease 2. A history of receiving an injection of Gentamicin in the affected ear 3. A history of receiving an injection of steroids in the affected ear 4. An adverse reaction to dexamethasone

Phase

III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Type of Study

Treatment

Scope

National

Location

University of Colorado Hospital

Principal Investigator
Stephen Cass,  MD, MPH/MSPH

Stephen Cass, MD, MPH/MSPH

Study ID

Protocol Number: 18-1269

More information available at ClinicalTrials.gov: NCT03664674

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