Sudden Hearing Loss Multi-center Clinical Trial

NCT02026479 | Unknown

• 1 other identifier: PUCRP201307
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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

Keywords

full-frequency sudden hearing loss; post auricular injection; glucocorticoid; multi-center

Outcome Measures

Primary Outcomes (1)

• Pure tone audiometry test

  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.

  Days 30

Secondary Outcomes (2)

• Tinnitus with Evaluation questionnaire

  days 14,30,90

• Vertigo with Evaluation questionnaire

  Day 14,30,90

Other Outcomes (1)

• the records of adverse reaction and event

  Day 2,4,7,14,30,90

Study Arms (3)

regular treatment comparator

EXPERIMENTAL

Ginaton

Drug: Ginaton

Dexamethasone Phosphate low dose

EXPERIMENTAL

5mg

Drug: Dexamethasone Phosphate

Dexamethasone Phosphate high dose

EXPERIMENTAL

10mg

Drug: Dexamethasone Phosphate

Interventions

Dexamethasone Phosphate DRUG

5mg; postauricular injection

Dexamethasone Phosphate low dose

Ginaton DRUG

40mg/pill, 3times/day,oral

regular treatment comparator

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Interventions

dexamethasone 21-phosphate; ginaton

Central Study Contacts

Lisheng Yu, MD

CONTACT

010-88325423; yulisheng68@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 29, 2013
• First Posted: January 3, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 3, 2014

Record last verified: 2013-12