UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024134 |
|---|---|
| Receipt number | R000027179 |
| Scientific Title | Comparative study on properties of ointment for oral cavity between hospital and out-of-hospital pharmacy preparations. |
| Date of disclosure of the study information | 2016/09/23 |
| Last modified on | 2018/03/26 12:11:31 |
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Basic information
Public title
Comparative study on properties of ointment for oral cavity between hospital and out-of-hospital pharmacy preparations.
Acronym
Comparative study of oral ointment
Scientific Title
Comparative study on properties of ointment for oral cavity between hospital and out-of-hospital pharmacy preparations.
Scientific Title:Acronym
Comparative study of oral ointment
Region
| Japan |
Condition
Condition
stomatitis
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate whether there are differences in properties as appearance and feeling on ointments for oral cavity that was prepared in out-of-hospital pharmacy compared with the preparation of our hospital in subjectivity of subjects.
Basic objectives2
Others
Basic objectives -Others
Subjective investigation of preparation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
properties
Key secondary outcomes
color,hardness,graininess,adhesive
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
About 0.1g per sample, apply to the buccal mucosa of subjects who are sound.
After decision, wipe off immediately and wash the mouth as needed.
Subjects judge all 22 kinds of samples between 1 to 5 days.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Wish to cooperate in this investigation, a determination can be made within the study period, those who there is no abnormality in the oral cavity
Key exclusion criteria
Those who use oral ointments for treatment with abnormality of oral cavity as stomatitis.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kumiko Makita |
Organization
Tokyo Medical and Dental University
Division name
Department of Pharmacy,University Hospital,School of Dental
Zip code
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
03-5803-5768
kmkmakita.dpha@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kumiko Makita |
Organization
Tokyo Medical and Dental University
Division name
Department of Pharmacy,University Hospital,School of Medicine
Zip code
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
03-5803-5768
Homepage URL
kmkmakita.dpha@tmd.ac.jp
Sponsor or person
Institute
Department of Pharmacy,University Hospital,School of Dental,Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
contribution
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
| 2016 | Year | 09 | Month | 23 | 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
| 2016 | Year | 09 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 21 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 23 | Day |
Last modified on
| 2018 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027179
