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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024759
Receipt No. R000028478
Scientific Title Health economic effect of leuprorelin acetate depot injection for 6 months (brand) for prostate cancer patients compared to that for 3 months (generic).
Date of disclosure of the study information 2016/11/08
Last modified on 2018/11/20

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Basic information
Public title Health economic effect of leuprorelin acetate depot injection for 6 months (brand) for prostate cancer patients compared to that for 3 months (generic).
Acronym Health economic effect of leuprorelin acetate depot injection for prostate cancer patients.
Scientific Title Health economic effect of leuprorelin acetate depot injection for 6 months (brand) for prostate cancer patients compared to that for 3 months (generic).
Scientific Title:Acronym Health economic effect of leuprorelin acetate depot injection for prostate cancer patients.
Region
Japan

Condition
Condition prostate cancer
Classification by specialty
Hematology and clinical oncology Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the health economic effect of leuprorelin acetate depot injection for 6 months (brand) compared to that for 3 months (generic).
Basic objectives2 Others
Basic objectives -Others not applicable
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Monetary value of reduced injection frequency
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

Not applicable
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria prostate cancer patients
Key exclusion criteria patients who cannot answer a questionnaire survey
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Rei Goto
Organization Keio University
Division name Graduate School of Business Administration
Zip code
Address 4-1-1 Hiyoshi Kohoku-ku, Yokohama Kanagawa, 223-8526 JAPAN
TEL 045-564-2536
Email reigoto@kbs.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomomi Takeshima
Organization Millian
Division name Japan Healthcare Practice and Data Analysis
Zip code
Address ACN Hanzomon Building 12F, 2-2-22 Kojimachi, Chiyoda-ku, Tokyo, Japan 102-0083
TEL 03-5211-7031
Homepage URL
Email tomomi.takeshima@milliman.inc

Sponsor
Institute Takeda Pharmaceutical Company Limited
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Company Limited
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
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
2016 Year 11 Month 08 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.tandfonline.com/doi/full/10.1080/13696998.2017.1362410
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 Completed
Date of protocol fixation
2016 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A questionnaire survey will be performed for the eligible patients in patient panel in research company.
To assess the generalizability of the survey, adult males who had injection within 1 year will be also subjected as another cohort.
The results of survey will be analyzed by conjoint analysis.

Management information
Registered date
2016 Year 11 Month 08 Day
Last modified on
2018 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028478

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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