Sudden Hearing Loss Multi-center Clinical Trial

NCT ID: NCT02026479

Last Updated: 2014-01-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-12-31

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.

Conditions

Full-frequency Sudden Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

regular treatment comparator

Ginaton

Group Type: EXPERIMENTAL

Ginaton

Intervention Type: DRUG

40mg/pill, 3times/day,oral

Dexamethasone Phosphate low dose

5mg

Group Type: EXPERIMENTAL

Dexamethasone Phosphate

Intervention Type: DRUG

5mg; postauricular injection

Dexamethasone Phosphate high dose

10mg

Group Type: EXPERIMENTAL

Dexamethasone Phosphate

Intervention Type: DRUG

10mg; postauricular injection

Interventions

Dexamethasone Phosphate

5mg; postauricular injection

Intervention Type: DRUG

Dexamethasone Phosphate

10mg; postauricular injection

Intervention Type: DRUG

Ginaton

40mg/pill, 3times/day,oral

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Li Sheng Yu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Lisheng Yu, MD

Role: CONTACT

yulisheng68@163.com

010-88325423

Other Identifiers

PUCRP201307

Identifier Type: -

Identifier Source: org_study_id