Otonomy OTO4811
Research type
Research Study
Full title
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.
IRAS ID
249494
Contact name
John Phillips
Contact email
Sponsor organisation
Otonomy, Inc.
Eudract number
2018-001464-35
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Meniere’s disease affects the function of the inner ear and causes a number of unpleasant symptoms in sufferers. Common symptoms include; feeling like the room is spinning (vertigo), ringing in the ears (tinnitus), feelings of pressure within the ear and eventual hearing loss.
There is no cure for Meniere’s disease. Current treatment tends to focus on relieving the vertigo symptoms, where it is thought that reducing inner ear fluid volume will improve the clinical picture. A number of other medical treatments are also used to relieve Meniere’s disease symptoms, including (but not limited to) antihistamines, anticholinergics, benzodiazepines and corticosteroids. Devices that pass low-pressure pulses into the ear, such as the Meniett device, can also be used to treat symptoms. Surgical methods of treatment are also available, but rarely successful. Thus, there is an unmet medical need for safe and effective therapies to address this debilitating disease.
This study will investigate the effectiveness of OTO-104 in Meniere’s disease. OTO-104 is made up of a medicine called dexamethasone (a synthetic steroid hormone) suspended in a liquid which turns to gel when administered to patients. The suspension liquid is known as a glycol polymer (in this case poloxamer 407) and this turns to gel at body temperature. OTO-104 will be injected into the ear membrane of patients in this study and its gel properties will help the dexamethasone medicine have a prolonged effect.
This study will be placebo-controlled, meaning that some patients will receive OTO-104 and some patients will receive an inactive substance (known as a placebo) for comparison purposes. This study will be randomised, meaning that patients will be randomly assigned to either the OTO-104 or the placebo groups. This study will also be double-blind, meaning that neither the patients or doctors will know which treatment group patients have been assigned to, this is to reduce bias in the study. In case of a medical emergency, treatment group assignment can be revealed.
REC name
London - Central Research Ethics Committee
REC reference
18/LO/1522
Date of REC Opinion
1 Nov 2018
REC opinion
Further Information Favourable Opinion