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

Sponsor:	Auris Medical, Inc.
Information provided by (Responsible Party):	Auris Medical, Inc.
ClinicalTrials.gov Identifier:	NCT01270282

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	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:

MedlinePlus related topics: Tinnitus

U.S. FDA Resources

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 ]

Estimated Enrollment:	72
Study Start Date:	February 2011
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AM-101 (single injection) AM-101 (single injection)	Drug: AM-101 Single intratympanic injection or triple intratympanic injection
Experimental: AM-101 (triple injection) AM-101 (triple injection)	Drug: AM-101 Single intratympanic injection or triple intratympanic injection
Placebo Comparator: Placebo Placebo (single injection or triple injection)	Drug: AM-101 Single intratympanic injection or triple intratympanic injection

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

Contacts

Contact: Thomas Meyer, PhD

ear@aurismedical.com

Locations

United States, Florida
University of Florida College of Medicine	Recruiting
Gainsville, Florida, United States, 32610-0264
United States, Kansas
University of Kansas Medical Center	Recruiting
Kansas City, Kansas, United States, 66160
United States, Kentucky
Advanced ENT & Allergy	Recruiting
Louisville, Kentucky, United States, 40207
United States, North Carolina
PMG Research of Winston-Salem	Recruiting
Winston-Salem, North Carolina, United States, 27103
Belgium
UZ Antwerp, Department of ENT	Recruiting
Edegem, Belgium, 2650
Gent University Hospital, Department of ENT	Recruiting
Gent, Belgium, 9000
Virga Jesseziekenhuis Hasselt	Recruiting
Hasselt, Belgium, 5300
Germany
HNO Praxis im Schlosscarree	Recruiting
Braunschweig, Germany, 38100
HNO Gemeinschaftspraxis	Recruiting
Heidelberg, Germany, 69126
HNO Praxis	Recruiting
Köln, Germany, 51061

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:	March 9, 2012
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 May 23, 2012