UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047396 |
|---|---|
| Receipt number | R000054053 |
| Scientific Title | A cohort study of the carteolol hydrochloride/latanoprost fixed-combination ophthalmic solution using claims database -comparison of persistence with the other fixed-combination ophthalmic solutions containing b-blocker/prostaglandin- |
| Date of disclosure of the study information | 2022/06/17 |
| Last modified on | 2023/06/07 13:00:40 |
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Basic information
Public title
A cohort study of the carteolol hydrochloride/latanoprost fixed-combination ophthalmic solution using claims database
Acronym
A cohort study of the carteolol hydrochloride/latanoprost fixed-combination ophthalmic solution using claims database
Scientific Title
A cohort study of the carteolol hydrochloride/latanoprost fixed-combination ophthalmic solution using claims database -comparison of persistence with the other fixed-combination ophthalmic solutions containing b-blocker/prostaglandin-
Scientific Title:Acronym
A cohort study of the carteolol hydrochloride/latanoprost fixed-combination ophthalmic solution using claims database
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether persistence with carteolol/latanoprost (CAR/LAT) ophthalmic solution is higher than that with other prostaglandin/b-blocker(PG/BB) ophthalmic solutions in glaucoma patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Persistence in the CAR/LAT and other PG/BB arms
Key secondary outcomes
･Persistence in the PG/BB and BB/CAI arms
･Persistence in the CAR/LAT and PG/BB arms
･Number of concomitant medications for glaucoma ophthalmic solutions at the start and end of Follow-up period of each target agent (a fixed combination is counted as one medication)
･Back ground of CAR/LAT and the other PG/BB arms
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[1]Patients who were diagnosed with target disease listed above during the enrollment period and for whom treatment with the target combination product glaucoma ophthalmic solutions was started (the start date of treatment is defined as the index date for each patient).
[2]Patients aged 20 years or older.
Key exclusion criteria
[1]Patients who are taking the target agent and the comparator agent at the same time during the continuation period.
Target sample size
14000
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Ouchi |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs Department
Zip code
540-0021
Address
3-2-27, Otedori, Chuo-ku, Osaka-shi, Osaka 540-0021
TEL
06-6943-7722
Ouchi.Kentaro@otsuka.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Ouchi |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs Department
Zip code
540-0021
Address
3-2-27, Otedori, Chuo-ku, Osaka-shi, Osaka 540-0021
TEL
06-6943-7722
Homepage URL
Ouchi.Kentaro@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Medical Affairs Department
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Medical Affairs Department
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
RIHDS Ethics Review Board
Address
2-5-5 Shibadaimon, Minato-ku, Tokyo Sumitomo Shibadaimon Building 12th floor, inside JMDC Co., Ltd.
Tel
03-5733-5010
rihds@jmdc.co.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
| 2022 | Year | 06 | Month | 17 | 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
14000
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
| 2002 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study uses JMDC Data Base
Management information
Registered date
| 2022 | Year | 04 | Month | 04 | Day |
Last modified on
| 2023 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054053
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
