UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030014 |
|---|---|
| Receipt number | 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 08:47:16 |
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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
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
masaki.fujita@kyowa-kirin.co.jp
Sponsor or person
Institute
Kyowa Hakko Kirin Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034274
