Sudden Hearing Loss Multi-center Clinical Trial

Peking University

Status: Unknown

Conditions: Full-frequency Sudden Hearing Loss

Treatments: Drug: Ginaton; Drug: Dexamethasone Phosphate

Study type: Interventional

Funder types: Other

Identifiers

NCT02026479

PUCRP201307

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

regular treatment comparator

Experimental group

Description:

Ginaton

Treatment:

Drug: Ginaton

Dexamethasone Phosphate low dose

Experimental group

Description:

5mg

Treatment:

Drug: Dexamethasone Phosphate

Drug: Dexamethasone Phosphate

Dexamethasone Phosphate high dose

Experimental group

Description:

10mg

Treatment:

Drug: Dexamethasone Phosphate

Drug: Dexamethasone Phosphate