Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus
NCT ID: NCT01270282
Last Updated: 2015-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
82 participants
INTERVENTIONAL
2011-02-28
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AM-101 0.81 mg/mL
Gel for injection; single or triple injection
AM-101 0.81 mg/mL
Placebo
Gel for injection; single or triple injection
Placebo
Interventions
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AM-101 0.81 mg/mL
Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Fluctuating tinnitus
* Intermittent tinnitus
* Meniere's Disease
* Ongoing acute or chronic otitis media or otitis externa.
18 Years
65 Years
ALL
No
Sponsors
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Auris Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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AM-101-CL-10-02
Identifier Type: OTHER
Identifier Source: secondary_id
AM-101-CL-10-02
Identifier Type: -
Identifier Source: org_study_id
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