search
Back to results

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

Primary Purpose

Tinnitus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AM-101 0.81 mg/mL
Placebo
Sponsored by
Auris Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Florida College of Medicine
  • University of Kansas Medical Center
  • Advanced ENT & Allergy
  • Summit Medical Group
  • PMG Research of Winston-Salem
  • UZ Antwerp, Department of ENT
  • Gent University Hospital, Department of ENT
  • Virga Jesseziekenhuis Hasselt
  • HNO Praxis im Schlosscarree
  • Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
  • HNO Gemeinschaftspraxis
  • HNO Praxis
  • Bundeswehrkrankenhaus Ulm
  • NZOZ Laryngologii Wojewodzki Szpital Specjalistyczny
  • NZOZ Centrum Medyczne LiMED
  • Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AM-101 0.81 mg/mL

Placebo

Arm Description

Gel for injection; single or triple injection

Gel for injection; single or triple injection

Outcomes

Primary Outcome Measures

The change in tinnitus loudness by magnitude estimation from Baseline to 90 days following the last injection

Secondary Outcome Measures

Standard audiological evaluations
Pure tone audiometry, tympanometry, otoscopy, tinnitus loudness match
Questionnaires evaluating the impact of tinnitus
Patient global impression of change scale, subjective tinnitus annoyance and loudness, tinnitus handicap questionaire
Pharmacokinetic measures

Full Information

First Posted
December 30, 2010
Last Updated
January 13, 2015
Sponsor
Auris Medical, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01270282
Brief Title
Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus
Acronym
TACTT1
Official Title
Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Auris Medical, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AM-101 0.81 mg/mL
Arm Type
Experimental
Arm Description
Gel for injection; single or triple injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Gel for injection; single or triple injection
Intervention Type
Drug
Intervention Name(s)
AM-101 0.81 mg/mL
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Standard audiological evaluations
Description
Pure tone audiometry, tympanometry, otoscopy, tinnitus loudness match
Time Frame
90 or 104 days
Title
Questionnaires evaluating the impact of tinnitus
Description
Patient global impression of change scale, subjective tinnitus annoyance and loudness, tinnitus handicap questionaire
Time Frame
90 or 104 days
Title
Pharmacokinetic measures
Time Frame
3 or 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Florida College of Medicine
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32610-0264
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Advanced ENT & Allergy
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Summit Medical Group
City
Berkeley Heights
State/Province
New Jersey
ZIP/Postal Code
07922
Country
United States
Facility Name
PMG Research of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
UZ Antwerp, Department of ENT
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Gent University Hospital, Department of ENT
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Virga Jesseziekenhuis Hasselt
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
HNO Praxis im Schlosscarree
City
Braunschweig
ZIP/Postal Code
38100
Country
Germany
Facility Name
Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
HNO Gemeinschaftspraxis
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
HNO Praxis
City
Köln
ZIP/Postal Code
51061
Country
Germany
Facility Name
Bundeswehrkrankenhaus Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
NZOZ Laryngologii Wojewodzki Szpital Specjalistyczny
City
Rzeszów
ZIP/Postal Code
35-055
Country
Poland
Facility Name
NZOZ Centrum Medyczne LiMED
City
Tarnowskie Góry
ZIP/Postal Code
42-600
Country
Poland
Facility Name
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs