UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049440 |
|---|---|
| Receipt number | R000055435 |
| Scientific Title | Intra-Tympanic Steroid Injection and Keeping Specified Head position for facial nerve palsy |
| Date of disclosure of the study information | 2022/11/06 |
| Last modified on | 2022/11/06 09:30:24 |
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Basic information
Public title
Intra-Tympanic Steroid Injection and Keeping Specified Head position for facial nerve palsy
Acronym
i-Siks for facial palsy
Scientific Title
Intra-Tympanic Steroid Injection and Keeping Specified Head position for facial nerve palsy
Scientific Title:Acronym
i-Siks for facial palsy
Region
| Japan |
Condition
Condition
peripheral facial palsy including Bell's palsy and Ranmay-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 and keeping specified head position from medical records of patients who underwent this treatment for facial nerve palsy.
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
Time it takes for signs of improvement to begin
Time it takes for the disease to recover completely
Incidence of adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 peripheral facial palsy and receiving systemic steroids who meet the following conditions and have a potentially poor prognosis; Yanagihara score of 8 or less and House-Brackmann grade 5 or higher, or Yanagihara score of 10-18 and House-Brackmann grade 4 without stapes reflex
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 a history of hypersensitivity to dexamethasone
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 Ktano 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
riekanai.ent@gmail.com
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Kanai |
Organization
Tazuke Kofukai Medical Research Institute Kitano Hospital
Division name
Department of Otolaryngology, Head & Neck Surgery
Zip code
530-84840
Address
2-4-20, Ougi-machi, Kita-ku, OSAKA, JAPAN
TEL
0663121221
Homepage URL
r-kanai@kitano-hp.or.jp
Sponsor or person
Institute
Tazukekofukai Medical Research Institute Ktano Hospital
Institute
Department
Personal name
Funding Source
Organization
Tazukekofukai Medical Research Institute Ktano Hospital
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
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 | 11 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The patients will be followed up for at least one year after treatment, and the following date will be investigated from the medical records : recovery rate (Yanagihara's score 36 or higher, House-Brackmann grade1) as primary outcome, and the time it takes for signs of improvement to begin, and time it takes for the disease to recover completely, and the incidence of adverse events for example, tympanic membrane perforation, middle ear infection, vertigo etc, as secondory outcomes.
Management information
Registered date
| 2022 | Year | 11 | Month | 06 | Day |
Last modified on
| 2022 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055435
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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