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AM-111 in the Treatment of Acute Inner Ear Hearing Loss

NCT02561091 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2023-09-14

No results posted yet for this study

Summary

The purpose of this research study is to test the effectiveness and safety of the study drug, AM-111. AM-111 is tested for the treatment of sudden sensorineural hearing loss where the cause is unknown.

Conditions

Interventions

OTHER

Placebo

DRUG

AM-111 0.4 mg/ml

DRUG

AM-111 0.8 mg/ml

Sponsors & Collaborators

  • Auris Medical AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Bulgaria

Study Locations

More Related Trials

Entities

Diseases

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 NCT02561091 on ClinicalTrials.gov