A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom

Phase 2

Completed

• Conditions: Meniere's Disease
• Interventions: Drug: Placebo; Drug: OTO-104

• Registration Number: NCT02265393
• Lead Sponsor: Otonomy, Inc.

Brief Summary

This is a 2-part study of OTO-104 in subjects with unilateral Meniere's disease in the United Kingdom. The first part is a randomized, placebo-controlled study comparing the safety profile of 2 injections of OTO-104 or placebo spaced 3 months apart. The second part is an open-label extension where all subjects will receive an additional 2 intratympanic injections of OTO-104 spaced 3 months apart. Each subject will participate on the study for a total of 1 year.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-15
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-08
• Disposition First Submitted: 2017-08-16
• Disposition First Submitted QC: 2017-08-16
• Last Update Submitted: 2017-08-16
• Disposition First Posted: 2017-08-18
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	OTO-104 vehicle
OTO-104	OTO-104	12 mg OTO-104 (dexamethasone)

Primary Outcome Measures

Name	Time	Method
Safety	Up to 1 Year	Otoscopy, audiometry, tympanometry, adverse events

Secondary Outcome Measures

Name	Time	Method
Meniere's Symptom Questionnaire	Up to 1 Year

Trial Locations

Locations (15)

Oxford University Hospitals; 🇬🇧 Bucks, United Kingdom

BMI The Edgbaston Hospital; 🇬🇧 Birmingham, United Kingdom

Leicester Royal Infirmary; 🇬🇧 Leicestershire, United Kingdom

Heatherwood & Wexham Park Hospitals; 🇬🇧 Berkshire, United Kingdom

Dorset County Hospital; 🇬🇧 Dorset, United Kingdom

Gloucestershire Royal Hospital; 🇬🇧 Gloucester, United Kingdom

John Radcliffe Hospital; 🇬🇧 Oxford, United Kingdom

Guy's Hospital and St. Thomas' Hospital; 🇬🇧 London, United Kingdom

Sheffield Teaching Hospitals & Sheffield Children's Hospital; 🇬🇧 Sheffield, United Kingdom

Birmingham University Hospital; 🇬🇧 Birmingham, United Kingdom

Southmead Hospital Bristol; 🇬🇧 Bristol, United Kingdom

Norfolk & Norwich University Hospital; 🇬🇧 Norfolk, United Kingdom

St. George Hospital; 🇬🇧 London, United Kingdom

Cambridge University Hospitals; 🇬🇧 Cambridge, United Kingdom

University Hospital of North Staffordshire, Stoke-on-Trent and Stafford General Hospital; 🇬🇧 Staffordshire, United Kingdom