UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028035 |
|---|---|
| Receipt number | R000032100 |
| Scientific Title | Examination of the durability density of mouthwash using the tricyclic antidepressant amitriptyline |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2017/07/01 18:25:51 |
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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
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
hisasaki@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032100
