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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040951
Receipt No. R000046731
Scientific Title A study of effect and adherence of miconazole oral tablets for oral candidiasis
Date of disclosure of the study information 2020/07/10
Last modified on 2020/06/29

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Basic information
Public title A study of effect and adherence of miconazole oral tablets for oral candidiasis
Acronym A study of effect and adherence of miconazole oral tablets
Scientific Title A study of effect and adherence of miconazole oral tablets for oral candidiasis
Scientific Title:Acronym A study of effect and adherence of miconazole oral tablets
Region
Japan

Condition
Condition oral candidiasis
Classification by specialty
Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical efficacy and adherence to medication of miconazole oral mucoadhesive tablet (Orabi) 50 mg, a synthetic imidazole antifungal drug with broad spectrum.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Treatment success rate on Day 14
Key secondary outcomes Confirmation of side effects due to oral use of Orabi tablets

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 Oravi 50mg once a day for 14 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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Candida positive in culture test
Key exclusion criteria Pregnant or breastfeeding
Milk allergy
Administration of antifungal drugs within 14 days
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Eiji
Middle name
Last name Kondo
Organization Shinshu University School of Medicine
Division name Department of Dentistry and Oral Surgery
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto, Japan
TEL 0263-37-2677
Email eiji@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Eiji
Middle name
Last name Kondo
Organization Shinshu University School of Medicine
Division name Department of Dentistry and Oral Surgery
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto, Japan
TEL 0263-37-2677
Homepage URL
Email eiji@shinshu-u.ac.jp

Sponsor
Institute Shinshu University School of Medicine, Department of Dentistry and Oral Surgery
Institute
Department

Funding Source
Organization Shinshu University School of Medicine, Department of Dentistry and Oral Surgery
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor MINAMINAGANO MEDICAL CENTER SHINONOI GENERAL HOSPITAL
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shinshu University School of Medicine, Department of Dentistry and Oral Surgery
Address 3-1-1 Asahi, Matsumoto, Japan
Tel 0263-37-2677
Email eiji@shinshu-u.ac.jp

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
2020 Year 07 Month 10 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
2020 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 10 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 06 Month 29 Day
Last modified on
2020 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046731

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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