UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003266 |
|---|---|
| Receipt number | 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 14:38:32 |
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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
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
Sponsor or person
Institute
Oral Diagnosis and Medicine, Graduate Schoolof Dental Medicine, Hokkaido University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003951
