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

Meniere's Disease Clinical Trial

Official title:

A 6-Month, Prospective, Randomized, Multicenter, Placebo-Controlled Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease Followed by a 6-Month Open-Label Extension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02265393
• Other study ID #: 104-201403
• Status: Completed
• Phase: Phase 2
• First received: October 9, 2014
• Last updated: August 16, 2017
• Start date: October 2014
• Est. completion date: May 2016

Study information

• Verified date: August 2017
• Source: Otonomy, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria includes, but is not limited to:

• Subject has a diagnosis of definite unilateral Meniere's disease.

• Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study.

Exclusion Criteria includes, but is not limited to:

• Subject is pregnant or lactating.

• Subject has a history of immunodeficiency disease.

• Subject has a history of previous endolymphatic sac surgery.

• Subject has a history of previous use of intratympanic gentamicin in the affected ear.

• Subject has a history of drop attacks.

• Subject has experienced an adverse reaction to intratympanic injection of steroids.

Related Conditions & MeSH terms

• Meniere Disease
• Meniere's Disease

Intervention

Drug:
• OTO-104

• Placebo

Locations

Country	Name	City	State
United Kingdom	Heatherwood & Wexham Park Hospitals	Berkshire
United Kingdom	Birmingham University Hospital	Birmingham
United Kingdom	BMI The Edgbaston Hospital	Birmingham
United Kingdom	Southmead Hospital Bristol	Bristol
United Kingdom	Oxford University Hospitals	Bucks
United Kingdom	Cambridge University Hospitals	Cambridge
United Kingdom	Dorset County Hospital	Dorset
United Kingdom	Gloucestershire Royal Hospital	Gloucester
United Kingdom	Leicester Royal Infirmary	Leicestershire
United Kingdom	Guy's Hospital and St. Thomas' Hospital	London
United Kingdom	St. George Hospital	London
United Kingdom	Norfolk & Norwich University Hospital	Norfolk
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	Sheffield Teaching Hospitals & Sheffield Children's Hospital	Sheffield
United Kingdom	University Hospital of North Staffordshire, Stoke-on-Trent and Stafford General Hospital	Staffordshire

Sponsors (1)

Lead Sponsor	Collaborator
Otonomy, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Otoscopy, audiometry, tympanometry, adverse events	Up to 1 Year
Secondary	Meniere's Symptom Questionnaire		Up to 1 Year