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Status unknownNCT02026479Updated Jan 3, 2014

Sudden Hearing Loss Multi-center Clinical Trial

An interventional study of Dexamethasone Phosphate and Dexamethasone Phosphate in Full-frequency Sudden Hearing Loss, sponsored by Peking University People's Hospital. Status unknown. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-01-03.

Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Full-frequency Sudden Hearing Loss

Keywords

  • full-frequency sudden hearing loss
  • post auricular injection
  • glucocorticoid
  • multi-center
03

In context

Hearing Loss

1,093 studies on the registry are indexed under Hearing Loss; 236 are open to participants now.

This study's planned enrollment of 300 is above the median of 40 across 764 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    regular treatment comparator

    Ginaton

    Drug: Ginaton

  • Experimental
    Dexamethasone Phosphate low dose

    5mg

    Drug: Dexamethasone Phosphate

  • Experimental
    Dexamethasone Phosphate high dose

    10mg

    Drug: Dexamethasone Phosphate

Interventions

  • DrugDexamethasone Phosphate

    5mg; postauricular injection

  • DrugDexamethasone Phosphate

    10mg; postauricular injection

  • DrugGinaton

    40mg/pill, 3times/day,oral

06

What researchers measure

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.

    Time frame: Days 30

Secondary outcomes

  1. 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.

    Time frame: days 14,30,90

  2. 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.

    Time frame: Day 14,30,90

Other outcomes

  1. the records of adverse reaction and event

    the rate of adverse reaction and event

    Time frame: Day 2,4,7,14,30,90

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02026479
Lead sponsor
Peking University People's Hospital
Responsible party
Li Sheng Yu (Professor, Peking University People's Hospital) — Principal investigator
First posted
Jan 3, 2014
Start date
Jan 2014
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Jan 3, 2014

Study contacts

Lisheng Yu, MD
Contact
yulisheng68@163.com
010-88325423
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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