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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029199
Receipt No. R000033377
Scientific Title Open study of ORM
Date of disclosure of the study information 2017/09/20
Last modified on 2018/09/28

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Basic information
Public title Open study of ORM
Acronym Open study of ORM
Scientific Title Open study of ORM
Scientific Title:Acronym Open study of ORM
Region
Japan

Condition
Condition periodontal disease
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the efficacy and safety of ORM in periodontal disease patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement of periodontal disease index at week4 .Taking photography of oral cavity at week4.
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 administer ORM twice daily for 4weeks
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
64 years-old >=
Gender Male and Female
Key inclusion criteria -Patients aged 20 to 64 years on the day of signing the informed consent
-Mild to moderate periodontal disease patients
Key exclusion criteria -Patients who have systemic diseases thought to affect evaluation of this study
-Patients who have serious oral diease thought to affect evaluation of this study
-Patients who smoke
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Shimabukuro
Organization Shimabukuro Dental Clinic
Division name -
Zip code
Address 1-5-6Tezukayamahigashi, Sumiyoshi, Osaka, Japan
TEL 06-6675-0418
Email smbk@dental.email.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Kawai
Organization ROHTO pharmaceutical CO.,LTD
Division name Clinical development group Development & Planning office
Zip code
Address 6-5-4Kunimidai, Kizugawa, Kyoto, Japan
TEL 0774-71-8820
Homepage URL
Email kawaim@rohto.co.jp

Sponsor
Institute ROHTO pharmaceutical CO.,LTD
Institute
Department

Funding Source
Organization ROHTO pharmaceutical CO.,LTD
Organization
Division
Category of Funding Organization Profit organization
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
2017 Year 09 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

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
2017 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 25 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 09 Month 20 Day
Last modified on
2018 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033377

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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