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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018524
Receipt No. R000021370
Scientific Title Effectiveness of mouth wash using pilocarpine acid for xerostomia patients
Date of disclosure of the study information 2015/08/03
Last modified on 2018/02/03

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Basic information
Public title Effectiveness of mouth wash using pilocarpine acid for xerostomia patients
Acronym Effectiveness of mouth wash using pilocarpine acid for xerostomia patients
Scientific Title Effectiveness of mouth wash using pilocarpine acid for xerostomia patients
Scientific Title:Acronym Effectiveness of mouth wash using pilocarpine acid for xerostomia patients
Region
Japan

Condition
Condition xerostomia patients
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effectiveness of mouth wash using pilocarpine acid
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Oral condition, salivary flow, number of bacteria, harmful phenomenon
from all over the use of drug to one month after use
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 from start of treatment to one month after completion of treatment
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients who plan radiation therapy in oral cancer
Key exclusion criteria patients who has already taken SALAGEN
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Youji Miyamoto
Organization Oral Sciences, clinical Dentistry, Institute of Biomedical Sciences, Tokushima University Graduate School
Division name Department of Oral Surgery
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima
TEL 088-633-7354
Email miyamoto@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiko Yamamura
Organization Oral Sciences, clinical Dentistry, Institute of Biomedical Sciences, Tokushima University Graduate S
Division name Department of Oral Surgery
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima
TEL 088-633-7354
Homepage URL
Email yamamura.yoshiko@tokushima-u.ac.jp

Sponsor
Institute Department of Oral Surgery, Oral Sciences, clinical Dentistry, Institute of Biomedical Sciences, Tokushima University Graduate School
Institute
Department

Funding Source
Organization Under application
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
2015 Year 08 Month 03 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 Preinitiation
Date of protocol fixation
2015 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 08 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
2015 Year 08 Month 03 Day
Last modified on
2018 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021370

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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