Sudden Hearing Loss Multi-center Clinical Trial

Not Applicable

• Conditions: Full-frequency Sudden Hearing Loss
• Interventions: Drug: Dexamethasone Phosphate; Drug: Ginaton

• Registration Number: NCT02026479
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-12
• Study First Submitted: 2013-12-29
• Study First Submitted QC: 2013-12-31
• Last Update Submitted: 2013-12-31
• Study Start: 2014-01
• Study First Posted: 2014-01-03
• Last Update Posted: 2014-01-03
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone Phosphate low dose	Dexamethasone Phosphate	5mg
Dexamethasone Phosphate high dose	Dexamethasone Phosphate	10mg
regular treatment comparator	Ginaton	Ginaton

Primary Outcome Measures

Name	Time	Method
Pure tone audiometry test	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 Outcome Measures

Name	Time	Method
Vertigo with Evaluation questionnaire	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.
Tinnitus with Evaluation questionnaire	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.