Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus

Completed · Phase 2 · Has a placebo group

Conditions studied: Tinnitus

In brief

The purpose of the study is to evaluate the therapeutic benefit and safety of intratympanic AM-101 injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus.

Key facts

Study ID

NCT01270282

Run by

Auris Medical, Inc.

People needed

82

Starts

2011-02-01

Expected to finish

2013-05-01

Last updated by the study team

2015-01-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Tinnitus following acute acoustic trauma, acute otitis media, middle ear surgery or inner ear barotrauma; with onset less than three months ago.

You may not qualify if…

• Tinnitus that is not completely maskable
• Fluctuating tinnitus
• Intermittent tinnitus
• Meniere's Disease
• Ongoing acute or chronic otitis media or otitis externa.

Where it is running

• University of Florida College of Medicine — Gainsville, Florida, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Advanced ENT & Allergy — Louisville, Kentucky, United States
• Summit Medical Group — Berkeley Heights, New Jersey, United States
• PMG Research of Winston-Salem — Winston-Salem, North Carolina, United States
• UZ Antwerp, Department of ENT — Edegem, Belgium
• Gent University Hospital, Department of ENT — Ghent, Belgium
• Virga Jesseziekenhuis Hasselt — Hasselt, Belgium
• HNO Praxis im Schlosscarree — Braunschweig, Germany
• HNO Praxis — Cologne, Germany
• Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie — Frankfurt am Main, Germany
• HNO Gemeinschaftspraxis — Heidelberg, Germany
• Bundeswehrkrankenhaus Ulm — Ulm, Germany
• NZOZ Laryngologii Wojewodzki Szpital Specjalistyczny — Rzeszów, Poland
• NZOZ Centrum Medyczne LiMED — Tarnowskie Góry, Poland
• Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie — Warsaw, Poland

Full record on ClinicalTrials.gov

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