Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus (TACTT1)
This study is ongoing, but not recruiting participants.
Sponsor:
Auris Medical, Inc.
Information provided by (Responsible Party):
Auris Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01270282
First received: December 30, 2010
Last updated: February 12, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tinnitus |
Drug: AM-101 0.81 mg/mL Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus |
Resource links provided by NLM:
Further study details as provided by Auris Medical, Inc.:
Primary Outcome Measures:
- The change in tinnitus loudness by magnitude estimation from Baseline to 90 days following the last injection [ Time Frame: 90 or 104 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Standard audiological evaluations [ Time Frame: 90 or 104 days ] [ Designated as safety issue: Yes ]Pure tone audiometry, tympanometry, otoscopy, tinnitus loudness match
- Questionnaires evaluating the impact of tinnitus [ Time Frame: 90 or 104 days ] [ Designated as safety issue: No ]Patient global impression of change scale, subjective tinnitus annoyance and loudness, tinnitus handicap questionaire
- Pharmacokinetic measures [ Time Frame: 3 or 14 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 72 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AM-101 0.81 mg/mL
Gel for injection; single or triple injection
|
Drug: AM-101 0.81 mg/mL |
|
Placebo Comparator: Placebo
Gel for injection; single or triple injection
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Tinnitus following acute acoustic trauma, acute otitis media, middle ear surgery or inner ear barotrauma; with onset less than three months ago.
Exclusion Criteria:
- Tinnitus that is not completely maskable
- Fluctuating tinnitus
- Intermittent tinnitus
- Meniere's Disease
- Ongoing acute or chronic otitis media or otitis externa.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270282
Locations
| United States, Florida | |
| University of Florida College of Medicine | |
| Gainsville, Florida, United States, 32610-0264 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Kentucky | |
| Advanced ENT & Allergy | |
| Louisville, Kentucky, United States, 40207 | |
| United States, New Jersey | |
| Summit Medical Group | |
| Berkeley Heights, New Jersey, United States, 07922 | |
| United States, North Carolina | |
| PMG Research of Winston-Salem | |
| Winston-Salem, North Carolina, United States, 27103 | |
| Belgium | |
| UZ Antwerp, Department of ENT | |
| Edegem, Belgium, 2650 | |
| Gent University Hospital, Department of ENT | |
| Gent, Belgium, 9000 | |
| Virga Jesseziekenhuis Hasselt | |
| Hasselt, Belgium, 3500 | |
| Germany | |
| HNO Praxis im Schlosscarree | |
| Braunschweig, Germany, 38100 | |
| Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie | |
| Frankfurt am Main, Germany, 60590 | |
| HNO Gemeinschaftspraxis | |
| Heidelberg, Germany, 69126 | |
| HNO Praxis | |
| Köln, Germany, 51061 | |
| Bundeswehrkrankenhaus Ulm | |
| Ulm, Germany, 89081 | |
| Poland | |
| NZOZ Laryngologii Wojewodzki Szpital Specjalistyczny | |
| Rzeszów, Poland, 35-055 | |
| NZOZ Centrum Medyczne LiMED | |
| Tarnowskie Góry, Poland, 42-600 | |
| Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie | |
| Warsaw, Poland, 02-097 | |
Sponsors and Collaborators
Auris Medical, Inc.
More Information
No publications provided
| Responsible Party: | Auris Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT01270282 History of Changes |
| Other Study ID Numbers: | AM-101-CL-10-02, AM-101-CL-10-02 |
| Study First Received: | December 30, 2010 |
| Last Updated: | February 12, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013