UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040951 |
|---|---|
| Receipt number | 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 22:01:49 |
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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
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
eiji@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine, Department of Dentistry and Oral Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046731
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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