UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031107 |
|---|---|
| Receipt number | R000035525 |
| Scientific Title | Efficacy and safety study of intratympanic dexamethasone treatment concurrent with standard oral prednisolone treatment for facial palsy |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2018/10/09 08:11:56 |
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Basic information
Public title
Efficacy and safety study of intratympanic dexamethasone treatment concurrent with standard oral prednisolone treatment for facial palsy
Acronym
Intratympanic dexamethasone therapy for facial palsy
Scientific Title
Efficacy and safety study of intratympanic dexamethasone treatment concurrent with standard oral prednisolone treatment for facial palsy
Scientific Title:Acronym
Intratympanic dexamethasone therapy for facial palsy
Region
| Japan |
Condition
Condition
Facial nerve palsy
Classification by specialty
| Neurology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessing the efficacy of concurrent intratympanic dexamethasone treatment as the facial nerve palsy treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Recovery of the facial nerve grading at 1,3,6,9,12 months after intervention
Key secondary outcomes
Improvement of complete recovery rate with intervention
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 |
Interventions/Control_1
Intratympanic dexamethasone application for 10 consecutive days
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who is diagnosed as Bell's palsy or Ramsay-Hunt syndrome.
The patients who can start the protocol within 7 days after onset.
20 years or older
Key exclusion criteria
Presence of non-viral inflammation in the idle ear.
The presence of the carriage state of viral or bacterial disease.
Middle ear or inner ear anomaly which makes it impossible to inject to the middle ear.
HbA1C > 6.5%
BUN >25 mg/dl or Serum creatinine level>2.0 mg/dl
ALT > 100 U/l or AST > 100/l
Severe protracted wound healing.
Signs of central facial palsy
Pregnancy, or possible pregnancy
Participate in other clinical traials within 3 months
Recurrent facial palsy
Treatment other than 60 mg of prednisolone and 1000 mg (Bell's palsy) or 3000 mg (Hunt syndrome)of oral valaciclovir within two days straight
History of facial nerve decompression surgery
The patients who are considered not to be appropriate for the clinical trial
Target sample size
53
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Murakami |
Organization
Nagoya City University, Graduate school of Medical sciences
Division name
Department of Otorhinolaryngology, Head and Neck surgery
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City, Aichi, 467-8601 Japan
TEL
052-853-8256
meikyo@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Inagaki |
Organization
Nagoya City University, Graduate school of Medical sciences
Division name
Department of Otorhinolaryngology, Head and Neck surgery
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City, Aichi, 467-8601 Japan
TEL
052-853-8256
Homepage URL
meijo_ent@hotmail.com
Sponsor or person
Institute
Nagoya City University, Graduate school of Medical sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
41-13-0004
Org. issuing International ID_1
Nagoya City University Institutional review board
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
名古屋市立大学病院(愛知県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 01 | 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
| 2014 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 01 | Day |
Last modified on
| 2018 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035525
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
