UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019418 |
|---|---|
| Receipt number | R000022461 |
| Scientific Title | effect of methotolexate on chronic non-infectious uvetis |
| Date of disclosure of the study information | 2015/11/11 |
| Last modified on | 2019/10/23 14:58:34 |
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Basic information
Public title
effect of methotolexate on chronic non-infectious uvetis
Acronym
effect of methotolexate on chronic non-infectious uvetis
Scientific Title
effect of methotolexate on chronic non-infectious uvetis
Scientific Title:Acronym
effect of methotolexate on chronic non-infectious uvetis
Region
| Japan |
Condition
Condition
chronic non-infectious uvetis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The utility of the methotlexte internal medicine is considered targeted for the chronic non-infectibility grape film flame patient as searching clinical study. It's the purpose of this research to make it clear whether a methotlexate internal medicine is useful as alternative therapy of an adrenal cortex steroid to a chronic non-infectibility grape film flame by this research. When it's indicated that a methotlexate internal medicine by this research is useful to a chronic non-infectibility grape film flame, it's possible to show a remedy besides the adrenal cortex steroid to the patient who suffers for these diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
investigation period concerned is estimated by the erythrocytes, white cell count, the number of platelets, the hemoglobin density and leukocyte fractionation
blood raw chemical inspectionGeneral protein, bilirubin, GOT,GPT,ChE and -GTP,LDH,ALP
other checks: Oxygen percentage humidity
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
methotolexate
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)The chronic non-infectibility uveritis patiant who continues for more than 3 months
2)20<=age<80
3)informed consent
Key exclusion criteria
1)severe river damage
2)severe kidney damage
3)pregnant women
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoji Yanai |
Organization
Yamaguchi univ.
Division name
Opthalmology
Zip code
Address
1-1-1,minami-kogushi, Ube,Yamaguchi
TEL
0836-22-2278
yanai@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoji Yanai |
Organization
Yamaguchi univ.
Division name
Opthalmology
Zip code
Address
1-1-1,minami-kogushi, Ube,Yamaguchi
TEL
0836-22-2278
Homepage URL
yanai@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi univ.
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi univ.
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
| 2015 | Year | 11 | Month | 11 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 12 | 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
| 2015 | Year | 10 | Month | 20 | Day |
Last modified on
| 2019 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022461
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
