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

January 13, 2015 updated by: Auris Medical, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Edegem, Belgium, 2650
        • UZ Antwerp, Department of ENT
      • Gent, Belgium, 9000
        • Gent University Hospital, Department of ENT
      • Hasselt, Belgium, 3500
        • Virga Jesseziekenhuis Hasselt
  • Germany
      • Braunschweig, Germany, 38100
        • HNO Praxis im Schlosscarree
      • Frankfurt am Main, Germany, 60590
        • Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
      • Heidelberg, Germany, 69126
        • HNO Gemeinschaftspraxis
      • Köln, Germany, 51061
        • HNO Praxis
      • Ulm, Germany, 89081
        • Bundeswehrkrankenhaus Ulm
  • Poland
      • Rzeszów, Poland, 35-055
        • NZOZ Laryngologii Wojewodzki Szpital Specjalistyczny
      • Tarnowskie Góry, Poland, 42-600
        • NZOZ Centrum Medyczne LiMED
      • Warsaw, Poland, 02-097
        • Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
  • United States
    • Florida
      • Gainsville, Florida, United States, 32610-0264
        • University of Florida College of Medicine
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Advanced ENT & Allergy
    • New Jersey
      • Berkeley Heights, New Jersey, United States, 07922
        • Summit Medical Group
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change in tinnitus loudness by magnitude estimation from Baseline to 90 days following the last injection
Time Frame: 90 or 104 days
90 or 104 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standard audiological evaluations
Time Frame: 90 or 104 days
Pure tone audiometry, tympanometry, otoscopy, tinnitus loudness match
90 or 104 days
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
90 or 104 days
Pharmacokinetic measures
Time Frame: 3 or 14 days
3 or 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Auris Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

December 30, 2010

First Submitted That Met QC Criteria

January 4, 2011

First Posted (Estimate)

January 5, 2011

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AM-101-CL-10-02 (Other Identifier: Auris Medical)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tinnitus

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe