UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002231
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Keio University School of medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002642

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.