UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016334 |
|---|---|
| Receipt number | R000018954 |
| Scientific Title | Facial nerve regeneration surgery using fibroblast growth factor in Bell's palsy and Hunt syndrome |
| Date of disclosure of the study information | 2015/01/26 |
| Last modified on | 2019/07/31 16:42:49 |
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Basic information
Public title
Facial nerve regeneration surgery using fibroblast growth factor in Bell's palsy and Hunt syndrome
Acronym
Facial nerve regenerating surgery for Bell's palsy and Hunt syndrome
Scientific Title
Facial nerve regeneration surgery using fibroblast growth factor in Bell's palsy and Hunt syndrome
Scientific Title:Acronym
Facial nerve regenerating surgery for Bell's palsy and Hunt syndrome
Region
| Japan |
Condition
Condition
Bell's palsy and Hunt syndrome
Classification by specialty
| Medicine in general | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of facial nerve regenerating surgery with bFGF for Bell's palsy and Hunt syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Non-recovery rate at 12 months after disease onset. Recovery is defined as an improvement of the House-Brackmann facial grading score 1-2.
Key secondary outcomes
Non-recovery rate at 6 months after disease onset, incidence rate of sequelae at 12 months after disease onset.
Postoperative bleeding which needs hemostasis in operating room and audiometric threshold elevation using air conduction pure tone audiometry at 250 Hz, 500 Hz, 1 kHz, 2 kHz, and 4 kHz test frequencies
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In intervention group: Facial nerve regenerating surgery with human recombinant bFGF (Fiblast spray, Kaken Pharmaceutical CO., Tokyo, Japan) via gelatin hydrogel.
Interventions/Control_2
In control group: Transmastoid conventional facial nerve decompression surgery
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult severe Bell's palsy and Hunt syndrome patients, who are older than 15 years, complete facial palsy(10 or less yanagihara score), degree of denervation exceeding 90% with ENoG and clinical follow unavailable for more than 12 month
Key exclusion criteria
The exclusion criteria are (1) pregnancy, (2) current neoplasms, (3) chronic kidney disease, (4) chronic liver disease, (5) immune-suppression (6) opt out decompression surgery
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Naohito |
| Middle name | |
| Last name | Hato |
Organization
Ehime University
Division name
Department of Otolaryngology Head and Neck surgery
Zip code
791-0295
Address
Shitsukawa, Toon city, Ehime Prefecture
TEL
0899605366
nhato@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Fujiwara |
Organization
Ehime University
Division name
Otolaryngology Head and Neck Surgery
Zip code
791-0295
Address
Shitsukawa, Toon city, Ehime
TEL
0899605366
Homepage URL
t.fujiwarabi@gmail.com
Sponsor or person
Institute
Department of Otolaryngology Head and Neck Surgery, Ehime University
Institute
Department
Personal name
Funding Source
Organization
Department of Otolaryngology Head and Neck Surgery, Ehime University
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
Institutional Review Board,Ehime University Hospital
Address
Shitsukawa, Toon, Ehime
Tel
089-960-5172
rinri@m.ehime-u.ac.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
| 2015 | Year | 01 | Month | 26 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 26 | Day |
Last modified on
| 2019 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018954
