UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002231 |
|---|---|
| Receipt number | R000002642 |
| Scientific Title | Evaluation of efficacy and safety of anti-fungal drug for treatment of oral candidiasis |
| Date of disclosure of the study information | 2009/07/27 |
| Last modified on | 2009/07/21 16:29:21 |
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Basic information
Public title
Evaluation of efficacy and safety of anti-fungal drug for treatment of oral candidiasis
Acronym
Anti-fungal drug therapy for oral candidiasis
Scientific Title
Evaluation of efficacy and safety of anti-fungal drug for treatment of oral candidiasis
Scientific Title:Acronym
Anti-fungal drug therapy for oral candidiasis
Region
| Japan |
Condition
Condition
oral candidiasis
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy for different usage of the itraconazole solution against the treatment of oral candidiasis
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
There is no significant differences of therapeutic effect between gargling group and internal use group.
The adverse effect of gargling group is lower than that of internal use.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
Itrizole internal use group: To take 20ml (200mg as itoraconazole) of Itorizole oral solution 1% before breakfast for 14 days.
Interventions/Control_2
Itrizole gargling group: Gargle 10ml (100mg as itraconazole) of Itorizole oral solution 1% after breakfast and dinner for 14 days.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patient with oral candidiasis
(2) Age of 20 to 75 years old
(3) Male and female
Key exclusion criteria
(1) Patient who has history for another anti-fungal drug usage within a week.
(2) Patient who has severe liver dysfunction
(3) Patient with pregnancy or brest-feeding
(4) Patient who hope pregnancy during trial duration
(5) Patient who is evaluated with unfitness by the physician
(6) Patient who is taking contraindicational drug
Target sample size
244
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Tsunoda |
Organization
Keio University School of Medicine
Division name
Department of Dentistry and Oral Surgery
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University School of Medicine
Division name
Department of Dentistry and Oral Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Keio University School of medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2009 | Year | 07 | Month | 27 | 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
| 2009 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 21 | Day |
Last modified on
| 2009 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002642
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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