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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024313
Receipt No. R000027879
Scientific Title Intratympanic steroid for Bell's palsy. Single-centre randomized controlled trial.
Date of disclosure of the study information 2016/10/07
Last modified on 2018/09/08

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Basic information
Public title Intratympanic steroid for Bell's palsy. Single-centre randomized controlled trial.
Acronym Intratympanic steroid for Bell's palsy
Scientific Title Intratympanic steroid for Bell's palsy. Single-centre randomized controlled trial.
Scientific Title:Acronym Intratympanic steroid for Bell's palsy
Region
Japan

Condition
Condition Bell's palsy and Hunt syndrome
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess intratypmanic steroid injection for Bell's palsy and Hunt syndrome
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Non-recovery rate(House-Brackmann grade 3 or more) at 6 month after disease onset.
We define recovery as House-Brackmann grade 1-2.
Primary outcome will be measured by blinded assesser.
Key secondary outcomes Non-recovery rate at 12 month after disease onset
Tympanic membrane perforation and any complications during intratympanic injection (e.g. vertigo, vomiting, and vasovagal syncope)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Control group: Conventional treatment (60 mg/day for 4 days, then taper) and anti-viral drug (Valacyclovir 3000mg/day for 5days)
Interventions/Control_2 Intervention group: Intratympanic steroid (0.5 ml Dexamethasone once or twice per week for 2weeks) add to conventional treatment
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
200 years-old >
Gender Male and Female
Key inclusion criteria Within 1 weeks after disease onset
Severe facial palsy (Yanagihara facial grade 12 or less)
Key exclusion criteria Pregnancy, breast-Feeding.
dementia and difficult to enroll trial.
Target sample size 108

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fujiwara Takashi
Organization Kurashiki Central Hospital
Division name Otolaryngology
Zip code
Address 1-1-1 Miwa, Kurashiki City, Okayama Prefecture
TEL 086-422-0210
Email t.fujiwarabi@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Nyuko
Organization Clinical Research Center Kurashiki Central Hospital
Division name Clinical Research Center Kurashiki Central Hospital
Zip code
Address 1-1-1 Miwa, Kurashiki City, Okayama Prefecture
TEL 086-422-0210
Homepage URL
Email tf14817@kchnet.or.jp

Sponsor
Institute Kurashiki Central Hospital
Institute
Department

Funding Source
Organization No funding
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 倉敷中央病院

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 07 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
2016 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
2018 Year 09 Month 08 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 06 Day
Last modified on
2018 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027879

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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