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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030014
Receipt No. R000034274
Scientific Title Specified Drug Use-Results Survey on "long-term use for Nouriast Tablet "
Date of disclosure of the study information 2017/12/01
Last modified on 2018/11/19

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Basic information
Public title Specified Drug Use-Results Survey on "long-term use for Nouriast Tablet "
Acronym Specified Drug Use-Results Survey on "long-term use for Nouriast Tablet "
Scientific Title Specified Drug Use-Results Survey on "long-term use for Nouriast Tablet "
Scientific Title:Acronym 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
1st name
Middle name
Last name Kouichi Kawamura
Organization Kyowa Hakko Kirin Co., Ltd.
Division name Pharmacovigilance and Quality Assurance Division
Zip code
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
1st name
Middle name
Last name Masaki Fujita
Organization Kyowa Hakko Kirin Co., Ltd.
Division name PV Operation Department ,Pharmacovigilance and Quality Assurance Division
Zip code
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)

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
2017 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2013 Year 04 Month 24 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000034274

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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