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Completed

NCT Number: NCT01270282

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

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.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UZ Antwerp, Department of ENT, Edegem, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AM-101 0.81 mg/mL

Drug

Placebo

Drug

Primary outcomes

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

    Time frame: 90 or 104 days

Secondary outcomes

  1. Standard audiological evaluations

    Time frame: 90 or 104 days

    Pure tone audiometry, tympanometry, otoscopy, tinnitus loudness match

  2. 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

  3. Pharmacokinetic measures

    Time frame: 3 or 14 days

Sponsors and collaborators

Lead sponsor

Auris Medical, Inc.

Industry

Registry information

Acronym: TACTT1

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 5, 2011
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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