UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024313 |
|---|---|
| Receipt number | 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 | 2020/01/10 16:16:47 |
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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
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
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 last follow up (6 to 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 5 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 | Takashi |
| Middle name | |
| Last name | Fujiwara |
Organization
Kurashiki Central Hospital
Division name
Otolaryngology
Zip code
710-8602
Address
1-1-1 Miwa, Kurashiki City, Okayama Prefecture
TEL
086-422-0210
t.fujiwarabi@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Nyuko |
Organization
Clinical Research Center Kurashiki Central Hospital
Division name
Clinical Research Center Kurashiki Central Hospital
Zip code
710-8602
Address
1-1-1 Miwa, Kurashiki City, Okayama Prefecture
TEL
086-422-0210
Homepage URL
tf14817@kchnet.or.jp
Sponsor or person
Institute
Kurashiki Central Hospital
Institute
Department
Personal name
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
IRB of Kurashiki Central Hospital
Address
Miwa 1-1-1, Kurashiki City, Okayama, Japan
Tel
+81-86-422-0210
tf14817@kchnet.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
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
| 2016 | Year | 10 | Month | 19 | Day |
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
| 2020 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027879
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| Registered date | File name |
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