UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Open-label crossover study for the efficasy of Escitalopram and Mecobalamin for patients with tinnitus.
Title of the study (Brief title)	The efficasy of Escitalopram for patients with tinnitus.
Region	Japan

Condition
Condition	tinnitus
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy of Escitalopram and Mecobalamin for the patients with tinnitus
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of Tinnitus Handicap Inventory
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-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	Medicine
Interventions/Control_1	Take Escitalopram
Interventions/Control_2	Take Mecobalamin
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1. with tinnitus 2.no changein spite of therapy for one month. 3.with depressive state 4. with informed consent
Key exclusion criteria	1.allergy for Escitalopram 2.arrhythmia and QT prolongation 3.heart failure 4.hepatic disorder 5.mental disorder 6.epilepsy 7.lactating 8.others
Target sample size	70

Research contact person
Name of lead principal investigator	Yuji Nakamaru
Organization	Hokkaido University Hospital
Division name	Department of Otolaryngology
Address	West 15, North 7, Kita-ku, Sapporo, Hokkaido, 060-8638, JAPAN.
TEL	011-716-1161
Email	nmaru@med.hokudai.ac.jp

Public contact
Name of contact person	Yuji Nakamaru
Organization	Hokkaido University Hospital
Division name	Department of Otolaryngology
Address	West 15, North 7, Kita-ku, Sapporo, Hokkaido, 060-8638, JAPAN.
TEL	011-716-1161
Homepage URL
Email	nmaru@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Hokkaido University Hospital
Organization
Division
Category of Funding Organization	Other
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	北海道大学病院

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 20 Day
Anticipated trial start date	2014 Year 05 Month 01 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	2014 Year 03 Month 14 Day
Last modified on	2018 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015672