UMIN-CTR Clinical Trial

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
Email	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
Email	e6417@cc.saga-u.ac.jp

Sponsor
Institute	Saga University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050868