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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014354
Receipt No. R000014646
Scientific Title Examination of the medication effect using duloxetine in the patients with burning mouth syndrome and glossodynia
Date of disclosure of the study information 2014/06/25
Last modified on 2019/08/08

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Basic information
Public title Examination of the medication effect using duloxetine in the patients with burning mouth syndrome and glossodynia
Acronym Examination of the medication effect using duloxetine in the patients with burning mouth syndrome and glossodynia
Scientific Title Examination of the medication effect using duloxetine in the patients with burning mouth syndrome and glossodynia
Scientific Title:Acronym Examination of the medication effect using duloxetine in the patients with burning mouth syndrome and glossodynia
Region
Japan

Condition
Condition burning mouth syndrome
glossodynia
Classification by specialty
Psychiatry Anesthesiology Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We prove the effect of medication using duloxetine of the patient with burning mouth syndrome and glossodynia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes duloxetine
six weeks from medication maintenance
daily activity of patients
psychology test
Key secondary outcomes

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 Duloxetine
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 burning mouth syndrome patients
glossodynia patients
Key exclusion criteria patients with grave disease
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuru Doi
Organization Graduate School of Biomedical Scinencice, Hiroshima University
Division name Dental Anesthesiology
Zip code
Address 1-2-3, minamikukasumi, hiroshima 734-8551, Japan
TEL 082-257-5733
Email doi326@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuru Doi
Organization Hiroshima University
Division name Dental Anesthesiology
Zip code
Address 1-2-3, minamikukasumi, hiroshima 734-8551, Japan
TEL 028-257-5733
Homepage URL
Email doi326@hiroshima-u.ac.jp

Sponsor
Institute Depertment of Dental Anesthesiology, Division of Clinical Mediccal Sience, Programs for Applide Biomedicine, Graduate School of Biomedical Scinencice, Hiroshima University
Institute
Department

Funding Source
Organization Scientific research funds
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 25 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
2013 Year 11 Month 20 Day
Date of IRB
2019 Year 08 Month 08 Day
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
2019 Year 08 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We prove the effect of medication using duloxetine of the patient with burning mouth syndrome and glossodynia

Management information
Registered date
2014 Year 06 Month 23 Day
Last modified on
2019 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=R000014646

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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