UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044521 |
|---|---|
| Receipt number | R000050868 |
| Scientific Title | Clinical evaluation on the pain-reducing effect of Aconinsan for burning mouth syndrome |
| Date of disclosure of the study information | 2021/07/05 |
| Last modified on | 2021/06/13 18:35:14 |
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Basic information
Public title
Clinical evaluation on the pain-reducing effect of Aconinsan for burning mouth syndrome
Acronym
Clinical evaluation on the pain-reducing effect of Aconinsan
Scientific Title
Clinical evaluation on the pain-reducing effect of Aconinsan for burning mouth syndrome
Scientific Title:Acronym
Clinical evaluation on the pain-reducing effect of Aconinsan
Region
| Japan |
Condition
Condition
Burning mouth syndrome
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation on the pain-reducing effect of Aconinsan for burning mouth syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of pain improvement by VAS after 3 months of treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Aconinsan group(32 people administerd Aconinsan 9T/day for 3months)
Interventions/Control_2
Amitriptyline group(32 people administerd Amitriptyline 10-150/day for 3months)
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patient diagnosed BMS
2)Patient aged from 20 to 90years old
3)Patient agreed this trial in writing
Key exclusion criteria
1)Patient suffer from Angle-closure Glaucoma
2)Patient have medical history of hypersensivity to prescription drug
3)Patient have medical history of cardiovascular disease and cerebrovascular disorder
4)Patient suffer from prostate disease
5)Patient who administered MAOI
6)Patient suffer from hyperthyroidism
7)Patient suffer from convulsive disorder
8)Patient suffer from manic depression
9)Patients with organic brain disorders or predisposition to schizophrenia
10)Patients who have or have had suicidal thoughts or suicide attempts
11)Patients taking other antidepressants, anti-epileptic drugs, anti-anxiety drugs, etc.
12)Patient who is judged inappropriate by doctor
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Yamashita |
Organization
Saga University Hospital
Division name
Department of oral and maxillofacial surgery
Zip code
8498501
Address
5-1-1 Nabeshima ,Saga, Japan
TEL
+81952342397
e6417@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | MORI |
Organization
Saga University Hospital
Division name
Department of oral and maxillofacial surgery
Zip code
849-8501
Address
5-1-1 Nabeshima Saga
TEL
+81952342397
Homepage URL
e6417@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Saga 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
Cinical Research Center,Saga Universiyu Hospital
Address
5-1-1 Nabeshima ,Saga, Japan
Tel
0952-34-3400
kenkyu-shinsei@ml.cc.saga-u.ac.j
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
| 2021 | Year | 07 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 13 | Day |
Last modified on
| 2021 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050868
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
