UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008735 |
|---|---|
| Receipt number | R000010260 |
| Scientific Title | Evaluation for efficacy and safety of Irsogladine maleate for oral lichen planus |
| Date of disclosure of the study information | 2012/08/20 |
| Last modified on | 2017/08/28 07:37:43 |
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Basic information
Public title
Evaluation for efficacy and safety of Irsogladine maleate for oral lichen planus
Acronym
Evaluation for efficacy of Irsogladine maleate for oral lichen planus
Scientific Title
Evaluation for efficacy and safety of Irsogladine maleate for oral lichen planus
Scientific Title:Acronym
Evaluation for efficacy of Irsogladine maleate for oral lichen planus
Region
| Japan |
Condition
Condition
oral lichen planus
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
efficacy and safety
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
pain
area
location
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
irsogladine maleate
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)patients with oral lichen planus
2)untreated patients
3)Patients who can discontinue use of any medication at least 2 weeks prior to admission to the study
4)outpatients
5)Signed informed consent forms are obtained by the patients
Key exclusion criteria
1)Contraindication toirsogladine maleate.
2)Pregnancy or women with suspected pregnancy.
3)Serious cardiac disease, serious hepatic disorder , renal disease.
4)The patients who could not be provided with informed consent.
5)Unsuitability for the trial based on clinical judgement.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yumiko OHBAYASHI |
Organization
Kagawa University
Division name
Department of Oral and Maxillofacial Surgery, Faculty of Medicine
Zip code
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture 761-0793, Japan
TEL
087-891-2227
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumiko OHBAYASHI |
Organization
Kagawa University
Division name
Department of Oral and Maxillofacial Surgery, Faculty of Medicine
Zip code
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture
TEL
087-891-2227
Homepage URL
yumiko@med.kagawa-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Kagawa University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
香川大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 20 | 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
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 20 | Day |
Last modified on
| 2017 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010260
