UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013421 |
|---|---|
| Receipt number | 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 13:02:19 |
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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
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
nmaru@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015672
