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Intracochlear Injection of Glucocorticoid

NCT07134075 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-08-21

No results posted yet for this study

Summary

This study is a prospective, randomized pilot study. To verify safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with total sudden sensorineural hearing loss safety and efficacy in total sudden sensorineural hearing loss patients as an early salvage therapy.

Conditions

  • Sudden Sensorineural Hearing Loss (SSNHL)

Interventions

DRUG

intracochlear triamcinolone acetonide injection

intracochlear triamcinolone acetonide injection of through the round window membrane

DRUG

intracochlear injection of dexamethasone through the round window membrane

intracochlear injection of dexamethasone sodium phosphate through the round window membrane

DRUG

intracochlear dexamethasone injection and intratympanic dexamethasone injection

intracochlear dexamethasone sodium phosphate injection of through the round window membrane, intratympanic dexamethasone sodium phosphate injection through the tympanic membrane

DRUG

intratympanic dexamethasone injection

intratympanic dexamethasone sodium phosphate injection (10mg/ml) through tympanic membrane，once every other day, for a total of 4 injections.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

    collaborator OTHER

  • Eye & ENT Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Yilai Shu, MD, Ph.D · Eye & ENT Hospital, Fudan University, Shanghai, China

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
2025-08-25
Primary Completion
2027-08-01
Completion
2027-08-01

Countries

  • China

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 NCT07134075 on ClinicalTrials.gov