UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Specified Drug Use-Results Survey on "long-term use for Nouriast Tablet "
Title of the study (Brief title)	Specified Drug Use-Results Survey on "long-term use for Nouriast Tablet "
Region	Japan

Condition
Condition	Parkinson's disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess information on the occurrence of adverse drug reactions(ADRs)under actual-useconditions, detect unexpected ADRS,and identify factrs that may affect the safety and efficacy of the drug in a specified drug use-results survey.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety 1.Development of ADR/infectious diseases (type, indication rate, etc.) 2.Investigation of factors considered to affect safety 3.Status of serious adverse events Effectiveness 1.Effective rate 2.Examination of factors considered to affect the effectiveness
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 and Female
Key inclusion criteria	Parkinson's disease patients who were treated with Nouriast Tablets for the first time to improve the wearing-off phenomenon on levodopa-containing preparation therapy.
Key exclusion criteria	When the contract is not concluded When the number of contract cases has been reached If the administration start date is out of the contract period For already registered patients When more than 15 days have elapsed from the administration start date Patients used for diseases other than approved efficacy benefits
Target sample size	1000

Research contact person
Name of lead principal investigator	Kouichi Kawamura
Organization	Kyowa Hakko Kirin Co., Ltd.
Division name	Pharmacovigilance and Quality Assurance Division
Address	1-9-2, Otemachi, Chiyoda-ku, Tokyo, Japan
TEL	03-5205-7233
Email	kouichi.kawamura@kyowa-kirin.co.jp

Public contact
Name of contact person	Masaki Fujita
Organization	Kyowa Hakko Kirin Co., Ltd.
Division name	PV Operation Department ,Pharmacovigilance and Quality Assurance Division
Address	1-9-2, Otemachi, Chiyoda-ku, Tokyo, Japan
TEL	03-5205-7233
Homepage URL
Email	masaki.fujita@kyowa-kirin.co.jp

Sponsor
Institute	Kyowa Hakko Kirin Co., Ltd.
Institute
Department

Funding Source
Organization	Kyowa Hakko Kirin Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 12 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 04 Month 24 Day
Anticipated trial start date	2013 Year 05 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	Prospective surveillance

Management information
Registered date	2017 Year 11 Month 17 Day
Last modified on	2018 Year 11 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034274