Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus
TACTT1
1 other identifier
interventional
82
4 countries
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2011
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2010
CompletedFirst Posted
Study publicly available on registry
January 5, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedJanuary 26, 2015
January 1, 2015
2.2 years
December 30, 2010
January 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
The change in tinnitus loudness by magnitude estimation from Baseline to 90 days following the last injection
90 or 104 days
Secondary Outcomes (3)
Standard audiological evaluations
90 or 104 days
Questionnaires evaluating the impact of tinnitus
90 or 104 days
Pharmacokinetic measures
3 or 14 days
Study Arms (2)
AM-101 0.81 mg/mL
EXPERIMENTALGel for injection; single or triple injection
Placebo
PLACEBO COMPARATORGel for injection; single or triple injection
Interventions
Eligibility Criteria
You may qualify if:
- Tinnitus following acute acoustic trauma, acute otitis media, middle ear surgery or inner ear barotrauma; with onset less than three months ago.
You may not qualify if:
- Tinnitus that is not completely maskable
- Fluctuating tinnitus
- Intermittent tinnitus
- Meniere's Disease
- Ongoing acute or chronic otitis media or otitis externa.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
University of Florida College of Medicine
Gainsville, Florida, 32610-0264, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Advanced ENT & Allergy
Louisville, Kentucky, 40207, United States
Summit Medical Group
Berkeley Heights, New Jersey, 07922, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103, United States
UZ Antwerp, Department of ENT
Edegem, 2650, Belgium
Gent University Hospital, Department of ENT
Ghent, 9000, Belgium
Virga Jesseziekenhuis Hasselt
Hasselt, 3500, Belgium
HNO Praxis im Schlosscarree
Braunschweig, 38100, Germany
HNO Praxis
Cologne, 51061, Germany
Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
Frankfurt am Main, 60590, Germany
HNO Gemeinschaftspraxis
Heidelberg, 69126, Germany
Bundeswehrkrankenhaus Ulm
Ulm, 89081, Germany
NZOZ Laryngologii Wojewodzki Szpital Specjalistyczny
Rzeszów, 35-055, Poland
NZOZ Centrum Medyczne LiMED
Tarnowskie Góry, 42-600, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Warsaw, 02-097, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2010
First Posted
January 5, 2011
Study Start
February 1, 2011
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
January 26, 2015
Record last verified: 2015-01