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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003266
Receipt No. R000003951
Scientific Title Efficacy and tolerability of paroxetine in patients with burning mouth syndrome
Date of disclosure of the study information 2010/03/01
Last modified on 2013/03/31

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Basic information
Public title Efficacy and tolerability of paroxetine in patients with burning mouth syndrome
Acronym Efficacy and tolerability of paroxetine in patients with burning mouth syndrome
Scientific Title Efficacy and tolerability of paroxetine in patients with burning mouth syndrome
Scientific Title:Acronym Efficacy and tolerability of paroxetine in patients with burning mouth syndrome
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the effectiveness and tolerability of paroxetine and determine the optimal regimen for patients with burnibg mouth syndrome.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The cumulative proportion of responders after 12 weeks of medication.
The incidence of adverse reaction during 12 weeks.
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A total of 80 subjects,12- week study.
Paroxetine hydrochloride is started at a dose of 10 mg once a day at after supper, and the dosage is adjusted every 2 weeks according to the clinical symptoms. If efficacy is not sufficient, the dosage is increased from 10 mg to a maximum dose of 30 mg.
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
25 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Depressive condition assessing by SDS or PHQ-9.
Tongue pain with a minimum duration of 6 months.
Key exclusion criteria Patients with clinically significant renal, hepatic cardiovascular diseases.
Subjects taking psychotropic drugs or antidepressant within the past four weeks
Abnormal hematologic examination finding
Candidiasis.
Pregnancy, nursing.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Yamazaki
Organization Hokkaido University Hospital
Division name Oral medicine
Zip code
Address Kita-14, Nishi-5, Kita-ku, Sapporo 060-8648, Japan
TEL 011-706-4349
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hokkaido University Hospital
Division name Oral medicine
Zip code
Address
TEL 011-706-4349
Homepage URL
Email

Sponsor
Institute Oral Diagnosis and Medicine, Graduate Schoolof Dental Medicine, Hokkaido University
Institute
Department

Funding Source
Organization Oral Diagnosis and Medicine, Graduate Schoolof Dental Medicine, Hokkaido University
Organization
Division
Category of Funding Organization Self funding
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(北海道)/ Hokkaido University Hospital (Hokkaido)

Other administrative information
Date of disclosure of the study information
2010 Year 03 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
2010 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 03 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
2010 Year 02 Month 28 Day
Last modified on
2013 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003951

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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