UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the durability density of mouthwash using the tricyclic antidepressant amitriptyline
Acronym	Basic research of amitriptyline oral rinse in healthy volunteers
Scientific Title	Examination of the durability density of mouthwash using the tricyclic antidepressant amitriptyline
Scientific Title:Acronym	Basic research of amitriptyline oral rinse in healthy volunteers
Region	Japan

Condition
Condition	oral mucocitis
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine durability concentrations as the pre-stage to examine the effect of the tricyclic antidepressant amitriptyline mouthwash on pain due to oral mucositis and investigate an effect and usability, the difference of the side effect that there is to the level
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	a feeling of irritation
Key secondary outcomes	a feeling of numbness, fatigue, sleepiness, and taste of oral rinse

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Healthy volunteers were provided an amitriptyline solution (0.05%, 0.10% and 0.20%), and they gargle with these solution for 5 seconds each section. They gargle once a day every second day.
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	healthy volunteer
Key exclusion criteria	People with inflammation and pain in the oral mucositis or using antidepressants or who used anesthetics or analgesics within 24 hours, and Pregnant women, lactating women or those who wish to become pregnant during this exam, and people who judged that person in charge is inappropriate for participation in this exam.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hisako Sasaki
Organization	Kitasato University Hospital
Division name	Pharmacy
Zip code
Address	Minami-ku, Sagamihara-shi, Kanagawa Kitasato 1-15-1
TEL	042-778-8111
Email	hisasaki@kitasato-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hisako Sasaki
Organization	Kitasato University Hospital
Division name	Pharmacy
Zip code
Address	Minami-ku, Sagamihara-shi, Kanagawa Kitasato 1-15-1
TEL	042-778-8111
Homepage URL
Email	hisasaki@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University Hospital
Institute
Department

Funding Source
Organization	itasato University pharmacy school
Organization
Division
Category of Funding Organization	Other
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	2017 Year 07 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	2014 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date	2014 Year 02 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	2017 Year 07 Month 01 Day
Last modified on	2017 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032100

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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