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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000047396
Receipt No. 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 2022/04/04

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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
Email 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
Email Ouchi.Kentaro@otsuka.jp

Sponsor
Institute Otsuka Pharmaceutical Co., Ltd.
Medical Affairs Department
Institute
Department

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
Email 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 No longer recruiting
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
2022 Year 04 Month 04 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054053

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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