Sudden Hearing Loss Multi-center Clinical Trial

Glucocorticoid Postauricular Injection Treatment for Sudden Hearing Loss: a Multi-center, Opened, Randomized, Controlled Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Full-frequency Sudden Hearing Loss
• Intervention / Treatment: Drug: Ginaton; Drug: Dexamethasone Phosphate; Drug: Dexamethasone Phosphate

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: regular treatment comparator; Ginaton	Drug: Ginaton; 40mg/pill, 3times/day,oral
Experimental: Dexamethasone Phosphate low dose; 5mg	Drug: Dexamethasone Phosphate; 5mg; postauricular injection; Drug: Dexamethasone Phosphate; 10mg; postauricular injection
Experimental: Dexamethasone Phosphate high dose; 10mg	Drug: Dexamethasone Phosphate; 5mg; postauricular injection; Drug: Dexamethasone Phosphate; 10mg; postauricular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tinnitus with Evaluation questionnaire	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.	days 14,30,90
Vertigo with Evaluation questionnaire	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.	Day 14,30,90

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the records of adverse reaction and event	the rate of adverse reaction and event	Day 2,4,7,14,30,90

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: December 29, 2013
• First Submitted That Met QC Criteria: December 31, 2013
• First Posted (Estimate): January 3, 2014

Study Record Updates

• Last Update Posted (Estimate): January 3, 2014
• Last Update Submitted That Met QC Criteria: December 31, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: glucocorticoid; full-frequency sudden hearing loss; post auricular injection; multi-center
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sudden; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101; Dexamethasone 21-phosphate
• Other Study ID Numbers: PUCRP201307

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No