Sudden Hearing Loss Multi-center Clinical Trial

Overview

The incidence of sudden hearing loss is rising obviously resent year, Glucocorticoids have obtained obvious effect in the treatment of sudden deafness. Postauricular hypodermic injection is the latest findings in clinical work and a new noninvasive way of administration which is gradually expanding research. The aim of this experiment is to verify and explore the efficacy and safety of the postauricular injection treatment with different doses of Glucocorticoids.

Full Title of Study: “Glucocorticoid Postauricular Injection Treatment for Sudden Hearing Loss: a Multi-center, Opened, Randomized, Controlled Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2016

Interventions

  • Drug: Dexamethasone Phosphate
    • 5mg; postauricular injection
  • Drug: Dexamethasone Phosphate
    • 10mg; postauricular injection
  • Drug: Ginaton
    • 40mg/pill, 3times/day,oral

Arms, Groups and Cohorts

  • Experimental: regular treatment comparator
    • Ginaton
  • Experimental: Dexamethasone Phosphate low dose
    • 5mg
  • Experimental: Dexamethasone Phosphate high dose
    • 10mg

Clinical Trial Outcome Measures

Primary Measures

  • Pure tone audiometry test
    • Time Frame: Days 30
    • Average change in hearing loss in decibel(dB) between the baseline and D 30 for the three contiguous frequencies with the worst hearing loss, and the treatment efficiency of the 30th day.

Secondary Measures

  • Tinnitus with Evaluation questionnaire
    • Time Frame: days 14,30,90
    • Average change in hearing loss in dB between the baseline and D 14, 90 for the three contiguous frequencies with the worst hearing loss; the treatment efficiency of the D 14,90; the treatment efficiency of the tinnitus in D14, 30, 90.
  • Vertigo with Evaluation questionnaire
    • Time Frame: Day 14,30,90
    • Average change in hearing loss in dB between the baseline and D 14, 90 for the three contiguous frequencies with the worst hearing loss; the treatment efficiency of the D 14,90; the treatment efficiency of the vertigo in D14, 30, 90.

Participating in This Clinical Trial

Inclusion Criteria

  • Older than 18 years, less than 60 years old; – patient with unilateral or bilateral(occured successively) acute sensorineural hearing loss(ASNHL) with onset 72hours or less ago. Mean hearing loss compared with the unaffected contralateral ear of at leat 60 dB; – Primary presentation within 2weeks; standard treatment for 2 weeks; – After 2weeks of standard treatment, sensorineural hearing loss (SHL) curative effect evaluation damaged frequencies >/=30 dB better than before; – Written informed consent before participation in the study. Exclusion Criteria:

SYSTEMIC DISEASE

  • History of tuberculosis or positive purified protein derivative (PPD); – Insulin-dependent diabetes mellitus; – Hypertension, poor control of BP(SBP/DBP)>=140mmHg); – History of rheumatic disease, e.g. rheumatoid arthritis, scleroderma, lupus, etc; – Serious psychiatric disease or psychiatric reaction to corticosteroids; – History of heart disease or transient ischemic attacks(TIAs); – Prior treatment with chemotherapeutic or immunosuppressive drugs; – Pancreatitis; – Active peptic ulcer disease or history of gastrointestinal bleeding; – History of HIV, Hepatitis B or C; – Chronic kidney failure; – Alcohol abuse; – Active shingles; – Severe osteoporosis or non-surgical aseptic necrosis of the hip; – Without contraindication with glucocorticoid, ginaton, Batroxobin. OTOLOGIC DISEASE – History of Meniere's disease; – History of chronic ear infection; – Prior history of sudden sensorineural hearing loss (SSNHL); – History of fluctuating hearing loss.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peking University People’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Li Sheng Yu, Professor – Peking University People’s Hospital
  • Overall Contact(s)
    • Lisheng Yu, MD, 010-88325423, yulisheng68@163.com

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