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| ID | Type | Description | Link |
|---|---|---|---|
| AM-101-CL-10-02 | Other Identifier | Auris Medical |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AM-101 0.81 mg/mL | Experimental | Gel for injection; single or triple injection |
|
| Placebo | Placebo Comparator | Gel for injection; single or triple injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AM-101 0.81 mg/mL | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The change in tinnitus loudness by magnitude estimation from Baseline to 90 days following the last injection | 90 or 104 days |
| Measure | Description | Time Frame |
|---|---|---|
| Standard audiological evaluations | Pure tone audiometry, tympanometry, otoscopy, tinnitus loudness match | 90 or 104 days |
| Questionnaires evaluating the impact of tinnitus | Patient global impression of change scale, subjective tinnitus annoyance and loudness, tinnitus handicap questionaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida College of Medicine | Gainsville | Florida | 32610-0264 | United States | ||
| University of Kansas Medical Center |
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|
| 90 or 104 days |
| Pharmacokinetic measures | 3 or 14 days |
| Kansas City |
| Kansas |
| 66160 |
| United States |
| Advanced ENT & Allergy | Louisville | Kentucky | 40207 | United States |
| Summit Medical Group | Berkeley Heights | New Jersey | 07922 | United States |
| PMG Research of Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| UZ Antwerp, Department of ENT | Edegem | 2650 | Belgium |
| Gent University Hospital, Department of ENT | Ghent | 9000 | Belgium |
| Virga Jesseziekenhuis Hasselt | Hasselt | 3500 | Belgium |
| HNO Praxis im Schlosscarree | Braunschweig | 38100 | Germany |
| HNO Praxis | Cologne | 51061 | Germany |
| Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie | Frankfurt am Main | 60590 | Germany |
| HNO Gemeinschaftspraxis | Heidelberg | 69126 | Germany |
| Bundeswehrkrankenhaus Ulm | Ulm | 89081 | Germany |
| NZOZ Laryngologii Wojewodzki Szpital Specjalistyczny | Rzeszów | 35-055 | Poland |
| NZOZ Centrum Medyczne LiMED | Tarnowskie Góry | 42-600 | Poland |
| Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie | Warsaw | 02-097 | Poland |
| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000592906 | PDCD5 protein, rat |
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