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Efficacy of AM 101 in Patients With Acute Inner Ear Tinnitus

NCT00860808 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2013-02-13

No results posted yet for this study

Summary

The purpose of the study is the evaluation of the therapeutic benefit of intratympanic AM 101 injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus following acute sensorineural hearing loss.

Conditions

  • Tinnitus

Interventions

DRUG

AM-101

Triple intratympanic injection (one on each day 1, 2, and 3)

Sponsors & Collaborators

  • Auris Medical AG

    lead INDUSTRY

Principal Investigators

  • Heinz Maier, MD · Bundeswehrkrankenhaus Ulm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-05-31
Completion
2011-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00860808 on ClinicalTrials.gov