UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014354
Receipt number 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 15:59:28

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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