UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety study of intratympanic dexamethasone treatment concurrent with standard oral prednisolone treatment for facial palsy
Title of the study (Brief title)	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	Shingo Murakami
Organization	Nagoya City University, Graduate school of Medical sciences
Division name	Department of Otorhinolaryngology, Head and Neck surgery
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City, Aichi, 467-8601 Japan
TEL	052-853-8256
Email	meikyo@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Akira Inagaki
Organization	Nagoya City University, Graduate school of Medical sciences
Division name	Department of Otorhinolaryngology, Head and Neck surgery
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City, Aichi, 467-8601 Japan
TEL	052-853-8256
Homepage URL
Email	meijo_ent@hotmail.com

Sponsor
Institute	Nagoya City University, Graduate school of Medical sciences
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 01 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035525