TerminatedPhase 3

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

Stopped: Negative Efficacy Results from the recently completed Phase 3 study 104-201506

United States142 participantsStarted 2016-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)

Timeframe: 6 Months

Trial details

NCT IDNCT02768662

SponsorOtonomy, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-09

Results submitted2022-10-20

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