A 6-Month Extension Study of OTO-104 in Meniere's Disease

Meniere's Disease Clinical Trial

Official title:

A 6-Month, Multicenter, Phase 3, Open-Label Extension Safety Study of OTO-104 Given At 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02768662
• Other study ID #: 104-201610
• Status: Terminated
• Phase: Phase 3
• Start date: August 2016
• Est. completion date: September 2017

Study information

• Verified date: December 2022
• Source: Otonomy, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (Phase 3 Study of OTO-104) in order to be eligible for this open-label extension study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 142
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria includes, but is not limited to:

• Subject has completed the Phase 2 OTO-104 1-Year Safety Study (104-201403) or Phase 3 (104-201508) clinical study.

• Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria

Exclusion Criteria includes, but is not limited to:

• Subject is pregnant or lactating.

• Subject has a history of immunodeficiency disease.

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

Related Conditions & MeSH terms

• Meniere Disease
• Meniere's Disease

Intervention

Drug:
• OTO-104
Single intratympanic injection of 12 mg OTO-104

Locations

Country	Name	City	State
United States	Many sites in Europe. Refer to the contact info listed below.	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Otonomy, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)	Otoscopic exams were conducted at each visit. It was considered important to understand if the tympanic membrane perforation that resulted from the IT injection persisted at the end of study visit (24 Weeks [Month 6]).	6 Months