UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparative study on properties of ointment for oral cavity between hospital and out-of-hospital pharmacy preparations.
Title of the study (Brief title)	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	Kumiko Makita
Organization	Tokyo Medical and Dental University
Division name	Department of Pharmacy,University Hospital,School of Dental
Address	1-5-45 Yushima Bunkyo-ku Tokyo
TEL	03-5803-5768
Email	kmkmakita.dpha@tmd.ac.jp

Public contact
Name of contact person	Kumiko Makita
Organization	Tokyo Medical and Dental University
Division name	Department of Pharmacy,University Hospital,School of Medicine
Address	1-5-45 Yushima Bunkyo-ku Tokyo
TEL	03-5803-5768
Homepage URL
Email	kmkmakita.dpha@tmd.ac.jp

Sponsor
Institute	Department of Pharmacy,University Hospital,School of Dental,Tokyo Medical and Dental University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027179