UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005953
Receipt number R000006861
Scientific Title Intratympanic injection with dexamethasone for sudden sensorineural hearing loss
Date of disclosure of the study information 2011/07/11
Last modified on 2012/10/21 16:31:03

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Basic information

Public title

Intratympanic injection with dexamethasone for sudden sensorineural hearing loss

Acronym

IT-DEX for SNHL

Scientific Title

Intratympanic injection with dexamethasone for sudden sensorineural hearing loss

Scientific Title:Acronym

IT-DEX for SNHL

Region

Japan


Condition

Condition

sudden sensorineural hearing loss

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To improve patient satisfaction and to improve the cure rate.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

pure tone audiogram and DPOAE

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

Intratympanic injection with dexamethasone

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

sudden sensorineural hearing loss and not improve within 14 days after initial treatment

Key exclusion criteria

acute low tone hearing loss

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Manabu Komori

Organization

The Jikei University School of Medicine

Division name

Department of Otorhinolaryngology

Zip code


Address

3-25-8 Nishi-shinbashi,Minato-ku,Tokyo,Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

The Jikei University School of Medicine

Division name

Department of Otorhinolaryngology

Zip code


Address


TEL


Homepage URL


Email

m_komori@jikei.ac.jp


Sponsor or person

Institute

The Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

The Jikei University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2011 Year 07 Month 11 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2011 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 07 Month 01 Day

Last follow-up date

2012 Year 10 Month 31 Day

Date of closure to data entry

2012 Year 10 Month 31 Day

Date trial data considered complete

2012 Year 10 Month 31 Day

Date analysis concluded

2012 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2011 Year 07 Month 08 Day

Last modified on

2012 Year 10 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006861


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name