UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018247 |
|---|---|
| Receipt number | R000021117 |
| Scientific Title | Exploratory study on the effects of antimicrobial therapy for refractory uveitis due to sarcoidosis. |
| Date of disclosure of the study information | 2015/07/15 |
| Last modified on | 2021/01/10 10:46:24 |
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Basic information
Public title
Exploratory study on the effects of antimicrobial therapy for refractory uveitis due to sarcoidosis.
Acronym
Antimicrobial therapy for uveitis due to sarcoidosis.
Scientific Title
Exploratory study on the effects of antimicrobial therapy for refractory uveitis due to sarcoidosis.
Scientific Title:Acronym
Antimicrobial therapy for uveitis due to sarcoidosis.
Region
| Japan |
Condition
Condition
Sarcoidosis
Classification by specialty
| Medicine in general | Pneumology | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the efficacy and safety of oral antibiotics, clarithromycin and miocycline, for uveitis due to sarcoidosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence or exacerbation of ocular inflammation.
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
Oral administration of antibiotics.
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) age between 20 and 80 years old.
2) from whom written informed consent could be obtained.
3) Being diagnosed as sarcoidosis, and having active intermediate or posterior uveitis.
4) satisfy more than one of the followings:
a) having grade one or more vitreous opacity
b) having retinal phlebitis that could be detected by fluorescein angiography.
c) having retinal yellow-white lesions that could be recorded by funds photograph.
Key exclusion criteria
satisfy one of the following:
1) having abnormal values by complete blood cell count.
2) having liver or kidney dysfunction.
3) having systemic infectious diseases such as active tuberculosis, hepatitis B, hepatitis C, or syphilis.
4) being allergenic against clarithromycin or minocyclin.
5) those who researcher consider to be not eligible for the study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Takase |
Organization
Tokyo medical and dental university
Division name
Ophthalmology
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
h.takase.oph@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Takase |
Organization
Tokyo medical and dental university
Division name
Ophthalmology
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
Homepage URL
h.takase.oph@tmd.ac.jp
Sponsor or person
Institute
Tokyo medical and dental university
Institute
Department
Personal name
Funding Source
Organization
Tokyo medical and dental university
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 | 07 | Month | 15 | 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 | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 08 | 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 | 07 | Month | 08 | Day |
Last modified on
| 2021 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021117
