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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013421
Receipt No. R000015672
Scientific Title Open-label crossover study for the efficasy of Escitalopram and Mecobalamin for patients with tinnitus.
Date of disclosure of the study information 2014/04/01
Last modified on 2018/01/29

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Basic information
Public title Open-label crossover study for the efficasy of Escitalopram and Mecobalamin for patients with tinnitus.
Acronym The efficasy of Escitalopram for patients with tinnitus.
Scientific Title Open-label crossover study for the efficasy of Escitalopram and Mecobalamin for patients with tinnitus.
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuji Nakamaru
Organization Hokkaido University Hospital
Division name Department of Otolaryngology
Zip code
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
1st name
Middle name
Last name Yuji Nakamaru
Organization Hokkaido University Hospital
Division name Department of Otolaryngology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2014 Year 03 Month 20 Day
Date of IRB
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

Other
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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015672

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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