Back to resultsSudden Hearing Loss Multi-center Clinical Trial
Primary Purpose
Full-frequency Sudden Hearing Loss
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexamethasone Phosphate
Dexamethasone Phosphate
Ginaton
Sponsored by
About this trial
This is an interventional treatment trial for Full-frequency Sudden Hearing Loss focused on measuring full-frequency sudden hearing loss, post auricular injection, glucocorticoid, multi-center
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
regular treatment comparator
Dexamethasone Phosphate low dose
Dexamethasone Phosphate high dose
Arm Description
Ginaton
5mg
10mg
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02026479
First Posted
December 29, 2013
Last Updated
December 31, 2013
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02026479
Brief Title
Sudden Hearing Loss Multi-center Clinical Trial
Official Title
Glucocorticoid Postauricular Injection Treatment for Sudden Hearing Loss: a Multi-center, Opened, Randomized, Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Full-frequency Sudden Hearing Loss
Keywords
full-frequency sudden hearing loss, post auricular injection, glucocorticoid, multi-center
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
regular treatment comparator
Arm Type
Experimental
Arm Description
Ginaton
Arm Title
Dexamethasone Phosphate low dose
Arm Type
Experimental
Arm Description
5mg
Arm Title
Dexamethasone Phosphate high dose
Arm Type
Experimental
Arm Description
10mg
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Phosphate
Intervention Description
5mg; postauricular injection
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Phosphate
Intervention Description
10mg; postauricular injection
Intervention Type
Drug
Intervention Name(s)
Ginaton
Intervention Description
40mg/pill, 3times/day,oral
Primary Outcome Measure Information:
Title
Pure tone audiometry test
Description
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.
Time Frame
Days 30
Secondary Outcome Measure Information:
Title
Tinnitus with Evaluation questionnaire
Description
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.
Time Frame
days 14,30,90
Title
Vertigo with Evaluation questionnaire
Description
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.
Time Frame
Day 14,30,90
Other Pre-specified Outcome Measures:
Title
the records of adverse reaction and event
Description
the rate of adverse reaction and event
Time Frame
Day 2,4,7,14,30,90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisheng Yu, MD
Phone
010-88325423
Email
yulisheng68@163.com
12. IPD Sharing Statement
Learn more about this trial
Sudden Hearing Loss Multi-center Clinical Trial
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