UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of intratympanic steroid injection for sudden sensorineural hearing loss
Title of the study (Brief title)	The efficacy of intratympanic steroid injection for sudden sensorineural hearing loss
Region	Japan

Condition
Condition	sudden sensorineural hearing loss
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of efficacy and safety of intratympanic steroid injection
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	pure-tone average hearing recovery rate
Key secondary outcomes	speech discrimination sccore DPOAE level

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	intratympanic steroid injection
Interventions/Control_2	contorol
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	Patients with sudden sensorineural hearing loss
Key exclusion criteria	Hypertension and diabetes in a noncompensated status, history of ischemic disorders (stroke, heart attack), Meniere's disease, retrocochlear diseases, trauma, radiation-induced HL, or any other identifiable etiology responsible or triggering sudden HL
Target sample size	40

Research contact person
Name of lead principal investigator	Yuichi Kurono
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Dept. of Otolaryngology-Head and Neck Surgery
Address	8-35-1, Sakuragaoka, Kagoshima, 890-8520, JAPAN
TEL	099-275-5410
Email

Public contact
Name of contact person
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Dept. of Otolaryngology-Head and Neck Surgery
Address
TEL	099-275-5410
Homepage URL
Email

Sponsor
Institute	Dept. of Otolaryngology-Head and Neck Surgery Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization	Dept. of Otolaryngology-Head and Neck Surgery Kagoshima University Graduate School of Medical and Dental Sciences
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	鹿児島大学病院

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 31 Day
Anticipated trial start date	2013 Year 04 Month 09 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	2013 Year 04 Month 09 Day
Last modified on	2018 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012196