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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000028035 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | oral mucocitis | ||
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 | |
Institute | Kitasato University Hospital |
Institute | |
Department |
Funding Source | |
Organization | itasato University pharmacy school |
Organization | |
Division | |
Category of Funding Organization | Other |
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IRB Contact (For public release) | |
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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 | |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
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Management information | |||||||
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Last modified on |
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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 |