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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038766
Receipt No. 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 2019/12/03

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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
Email 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
Email j.yamamoto@ono.co.jp

Sponsor
Institute ONO PHARMACEUTICAL CO., LTD.
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
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 Preinitiation
Date of protocol fixation
2019 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 03 Day
Last follow-up date
2019 Year 12 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.

Management information
Registered date
2019 Year 12 Month 03 Day
Last modified on
2019 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044185

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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