UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036352 |
|---|---|
| Receipt number | R000041415 |
| Scientific Title | MGD in BPH |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2019/03/30 09:49:01 |
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Basic information
Public title
Meibomian gland related parameters in patients with benign hyperplastic prostata (BPH)
Acronym
MGD in BPH
Scientific Title
MGD in BPH
Scientific Title:Acronym
MGD in BPH
Region
| Japan |
Condition
Condition
benign prostatic hypertrophy
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between meibomian gland related parameters and BPH
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between MGD severity and kinds of anti-BPH drugs
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
meibography score, lid margin score, BUT, meibum grade, SPK, tear meniscus height, Schirmer
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male
Key inclusion criteria
Patients with anti-BPH drugs
Key exclusion criteria
Acute inflammation diseases
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
1120002
Address
Saitama City
TEL
+81486865588
ritoh@za2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
3370042
Address
Saitama City
TEL
+81486865588
Homepage URL
ritoh@za2.so-net.ne.jp
Sponsor or person
Institute
Itoh Clinic
Institute
Department
Personal name
Funding Source
Organization
Lid and meibomian gland working group
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
Itoh Clinic
Address
Saitama City
Tel
+81486865588
ritoh@za2.so-net.ne.jp
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
| 2019 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A multi-center study in Itoh Clinic, Kuki Kawashima Eye clinic, Omiya Hamada Eye Clinic, and Mizoguchi Eye Clinic.
Management information
Registered date
| 2019 | Year | 03 | Month | 30 | Day |
Last modified on
| 2019 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041415
| 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 |
