UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048662
Receipt number R000055436
Scientific Title Intra-tympanic steroid injection for peripheral facial nerve palsy
Date of disclosure of the study information 2022/08/13
Last modified on 2022/08/13 17:37:15

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Basic information

Public title

Intra-tympanic steroid injection for peripheral facial nerve palsy

Acronym

Intra-tympanic steroid injection for peripheral facial nerve palsy

Scientific Title

Intra-tympanic steroid injection for peripheral facial nerve palsy

Scientific Title:Acronym

Intra-tympanic steroid injection for peripheral facial nerve palsy

Region

Japan


Condition

Condition

peripheral facial palsy including Bell's palsy and Ransay-Hunt syndrome

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of intra-tympanic steroid injection in patients with peripheral facial nerve palsy who may have a poor prognosis even after systemic steroid administration, and in patients who cannot receive systemic steroid administration for any reason

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Yanagihara's score, House-Brackmann grade and recovery rate 1 year after this therapy

Key secondary outcomes

The period taken facial nerve palsy to recover
Incidence of adverse events


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

Patients are injected Dexamethasone into the tympanic cavity via tympanic mambrane at least 7 times.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients diagnosed with peripherai facial palsy and treated with systemic steroid therapy, who have an ENoG of 10% or less after 10 days of onset

Patients diagnosed with peripheral facial palsy who are at high risk of complications from steroid administration due to their general condition or comorbidities and for whom systemic administration is not possible

Key exclusion criteria

Patients with morphological abnormalities or severe infection of the external auditory canal or middle ear

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Shin-ichi
Middle name
Last name Kanemaru

Organization

Tazukekofukai Medical Research Institute Kitano Hospital

Division name

Department of Otolaryngology, Head & Neck Surgery

Zip code

5308480

Address

2-4-20, Ougi-machi, Kita-ku, OSAKA, JAPAN

TEL

0663121221

Email

s-kanemaru@kitano-hp.or.jp


Public contact

Name of contact person

1st name Rie
Middle name
Last name Kanai

Organization

Tazukekofukai Medical Research Institute Kitano Hospital

Division name

Department of Otolaryngology, Head & Neck Surgery

Zip code

530-8480

Address

2-4-20, Ougi-machi, Kita-ku, OSAKA, JAPAN

TEL

0663121221

Homepage URL


Email

riekanai.ent@gmail.com


Sponsor or person

Institute

Tazukekofukai Medical Research Institute Kitano Hospital

Institute

Department

Personal name



Funding Source

Organization

none

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

Tazuke Kofukai Medical Research Institute Kitano Hospital

Address

2-4-20, Ougi-machi, Kita-ku, OSAKA, JAPAN

Tel

0663121221

Email

r-kanai@kitano-hp.or.jp


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

2022 Year 08 Month 13 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

Open public recruiting

Date of protocol fixation

2016 Year 09 Month 28 Day

Date of IRB

2016 Year 09 Month 28 Day

Anticipated trial start date

2016 Year 09 Month 28 Day

Last follow-up date

2022 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 08 Month 13 Day

Last modified on

2022 Year 08 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055436


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name