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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01270282
First received: December 30, 2010
Last updated: July 22, 2013
Last verified: July 2013
  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 ]

Enrollment: 82
Study Start Date: February 2011
Study Completion Date: May 2013
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: July 22, 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 April 15, 2014