UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038766 |
|---|---|
| Receipt number | R000044185 |
| Scientific Title | Large-scale database study to investigate prescription status of Parkinson's disease drug using data of dispensing fees |
| Date of disclosure of the study information | 2019/12/03 |
| Last modified on | 2022/10/25 13:15:52 |
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Basic information
Public title
Large-scale database study to investigate prescription status of Parkinson's disease drug using data of dispensing fees
Acronym
Database study to investigate prescription status of Parkinson's disease drug
Scientific Title
Large-scale database study to investigate prescription status of Parkinson's disease drug using data of dispensing fees
Scientific Title:Acronym
Database study to investigate prescription status of Parkinson's disease drug
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate prescription status of Parkinson's disease drug
Basic objectives2
Others
Basic objectives -Others
To investigate prescription status of Parkinson's disease drug, like drug type, dose per day, number of doses, number of tablets and dose timing using data of dispensing fees for patients who underwent Parkinson's disease drug throughout defined period
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Trends in prescriptions for Parkinson's disease drug
(2) Trends in prescriptions for levodopa
(3) Trends in prescriptions for dopamine concomitant drugs
(4) Trends in prescriptions for individual dopamine concomitant drugs
Key secondary outcomes
(1) Change in the proportion of patients who underwent dopamine concomitant drugs
(2) Correlation analysis between Levodopa and other Parkinson's disease drug
(3) Correlation analysis between Levodopa and dopamine concomitant drugs
(4) Analysis of dose timing
(5) Analysis of background
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 and Female
Key inclusion criteria
Patients who underwent first Parkinson's disease drug from January 1, 2009 to October 31, 2018 and who were registered in the database of dispensing fees owned by the research institutes (Period of data: January 1, 2009 to October 31, 2019).
Key exclusion criteria
no matching the key inclusion criteria
Target sample size
15000
Research contact person
Name of lead principal investigator
| 1st name | Futoshi |
| Middle name | |
| Last name | Kinoshita |
Organization
ONO PHARMACEUTICAL CO., LTD.
Division name
Medical Affairs
Zip code
541-8564
Address
8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka-shi, Japan
TEL
06-6263-2992
f.kinoshita@ono.co.jp
Public contact
Name of contact person
| 1st name | Junki |
| Middle name | |
| Last name | Yamamoto |
Organization
ONO PHARMACEUTICAL CO., LTD.
Division name
Medical Affairs
Zip code
541-8564
Address
8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka-shi, Japan
TEL
06-6263-2992
Homepage URL
j.yamamoto@ono.co.jp
Sponsor or person
Institute
ONO PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ONO PHARMACEUTICAL CO., LTD.
Address
8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka-shi, Japan
Tel
06-6263-2992
n.nishiwaki@ono.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
| 2019 | Year | 12 | Month | 03 | Day |
Related information
URL releasing protocol
https://webview.isho.jp/journal/detail/abs/10.11477/mf.1416201752
Publication of results
Published
Result
URL related to results and publications
https://webview.isho.jp/journal/detail/abs/10.11477/mf.1416201752
Number of participants that the trial has enrolled
19887
Results
Regading levodopa,the numberof doses,the numberof tablets,and the amount prescribed increased overtime.As for the transition of PD drugs,although the numberof doses showed an increasing trend similar to thatoflevodopa,the number of tablets showed a furtherincreasing trend,and the numberofconcomitant drugs increased over time.In addition,a weak correlation was observed between the increasein the amount oflevodopa and the numberof concomitant drugs increased over time.
Results date posted
| 2022 | Year | 10 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with Parkinson's disease registered in Japan Medical Information Research Institute (JMIRI) prescription database and fulfilling the definition of this study.
Participant flow
none
Adverse events
none
Outcome measures
Changes in Prescriptions for Parkinson's Disease Drugs
Prescription trends for levodopa
Prescription trend levodopa adjuvants
Prescription trends for individual levodopa adjuvants drugs
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study uses database of dispensing fees. The data is anonymized and no identifiable personal information is included in the database. Therefore, this study does not require approval by IRB.
Management information
Registered date
| 2019 | Year | 12 | Month | 03 | Day |
Last modified on
| 2022 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044185
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| Research case data specifications | |
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| Registered date | File name |
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