UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024759 |
|---|---|
| Receipt number | 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 15:03:24 |
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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
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
tomomi.takeshima@milliman.inc
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028478
| 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 |
