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Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus (TACTT1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01270282
Recruitment Status : Completed
First Posted : January 5, 2011
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Tinnitus Drug: AM-101 0.81 mg/mL Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. The change in tinnitus loudness by magnitude estimation from Baseline to 90 days following the last injection [ Time Frame: 90 or 104 days ]

Secondary Outcome Measures :
  1. Standard audiological evaluations [ Time Frame: 90 or 104 days ]
    Pure tone audiometry, tympanometry, otoscopy, tinnitus loudness match

  2. Questionnaires evaluating the impact of tinnitus [ Time Frame: 90 or 104 days ]
    Patient global impression of change scale, subjective tinnitus annoyance and loudness, tinnitus handicap questionaire

  3. Pharmacokinetic measures [ Time Frame: 3 or 14 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270282


Locations
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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
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Responsible Party: Auris Medical, Inc.
ClinicalTrials.gov Identifier: NCT01270282    
Other Study ID Numbers: AM-101-CL-10-02
AM-101-CL-10-02 ( Other Identifier: Auris Medical )
First Posted: January 5, 2011    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases