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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000019418
Receipt No. 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

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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
Email 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
Email yanai@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi univ.
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022461

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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