Full-frequency Sudden Hearing LossNCT02026479
Sudden Hearing Loss Multi-center Clinical Trial
A study testing Dexamethasone Phosphate and Ginaton in people with Full-frequency Sudden Hearing Loss, run by Peking University People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Full-frequency Sudden Hearing Loss
- What is being tested?
- Dexamethasone Phosphate and Ginaton
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Full-frequency Sudden Hearing Loss
- Being tested
- Dexamethasone Phosphate, Ginaton
- Keywords
- full-frequency sudden hearing loss, post auricular injection, glucocorticoid, multi-center
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone PhosphateDrug
5mg; postauricular injection
Dexamethasone PhosphateDrug
10mg; postauricular injection
GinatonDrug
40mg/pill, 3times/day,oral
| Study group | Role | What they receive |
|---|---|---|
| regular treatment comparator | Experimental | Ginaton Receives: Drug: Ginaton |
| Dexamethasone Phosphate low dose | Experimental | 5mg Receives: Drug: Dexamethasone Phosphate |
| Dexamethasone Phosphate high dose | Experimental | 10mg Receives: Drug: Dexamethasone Phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 30
Secondary outcomes (2)
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.
Measured: 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.
Measured: Day 14,30,90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Full-frequency Sudden Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Sheng Yu, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026479
- Sponsor's protocol ID
- PUCRP201307
- Status last verified
- Dec 2013
- First submitted
- 29 Dec 2013
- Last updated
- 3 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucocorticoid Postauricular Injection Treatment for Sudden Hearing Loss: a Multi-center, Opened, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02026479
- Acronym / sponsor ID
- PUCRP201307
- Conditions
- Full-frequency Sudden Hearing Loss
- Keywords
- full-frequency sudden hearing loss, post auricular injection, glucocorticoid, multi-center
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 3 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| regular treatment comparator | Experimental | Drug: GinatonGinaton |
| Dexamethasone Phosphate low dose | Experimental | Drug: Dexamethasone Phosphate5mg |
| Dexamethasone Phosphate high dose | Experimental | Drug: Dexamethasone Phosphate10mg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone Phosphate5mg; postauricular injection | Drug | Dexamethasone Phosphate low dose |
| Dexamethasone Phosphate10mg; postauricular injection | Drug | Dexamethasone Phosphate high dose |
| Ginaton40mg/pill, 3times/day,oral | Drug | regular treatment comparator |
Primary outcome
Pure tone audiometry test
Time frame: Days 30
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.
2 secondary outcomes
Tinnitus with Evaluation questionnaire
Time frame: days 14,30,90
Vertigo with Evaluation questionnaire
Time frame: Day 14,30,90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone Phosphate and Ginaton in people with Full-frequency Sudden Hearing Loss, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisheng Yu, MD (010-88325423, yulisheng68@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pure tone audiometry test (time frame: Days 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2014.