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Safety and Efficacy of STR001-IT and STR001-ER in Patients With SSHL

NCT03331627 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2020-03-25

No results posted yet for this study

Summary

a multicenter, double-blind, placebo-controlled study in patients with Sudden Sensorineural Hearing Loss (SSHL). Patients will be treated with STR001 thermogel (STR001-IT) / STR001 tablets (STR001-ER) and corresponding Placebo on top of standard of care.

Conditions

  • Acute Hearing Loss

Interventions

DRUG

STR001-IT and STR001-ER

STR001-IT intrataympanic injection and STR001-ER tablet

Sponsors & Collaborators

  • Strekin AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-24
Primary Completion
2020-02-06
Completion
2020-02-06

Countries

  • Czechia
  • Germany
  • Switzerland

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 NCT03331627 on ClinicalTrials.gov