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AM-101 in the Treatment of Acute Tinnitus 3

NCT02040194 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 893

Last updated 2023-09-14

No results posted yet for this study

Summary

The purpose of this research study is to test the safety and effectiveness of the study drug, AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with tinnitus can take part in the study, if their tinnitus started within the last 3 months or within the last \>3 to 6 months.

Conditions

  • Tinnitus

Interventions

DRUG

AM-101

AM-101 gel for intratympanic injection

DRUG

Placebo

Placebo gel for intratympanic injection

Sponsors & Collaborators

  • Auris Medical AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2017-12-28
Completion
2017-12-28

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT02040194 on ClinicalTrials.gov