UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037390 |
|---|---|
| Receipt number | R000042629 |
| Scientific Title | An exploratory study to optimize the administration of COMT inhibitor on LCIG therapy |
| Date of disclosure of the study information | 2019/07/16 |
| Last modified on | 2019/07/16 21:44:33 |
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Basic information
Public title
An exploratory study to optimize the administration of COMT inhibitor on LCIG therapy
Acronym
Levodopa pharmacokinetics on concomitant use of LCIG therapy and COMT inhibitor
Scientific Title
An exploratory study to optimize the administration of COMT inhibitor on LCIG therapy
Scientific Title:Acronym
Levodopa pharmacokinetics on concomitant use of LCIG therapy and COMT inhibitor
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effective administration method of COMT inhibitor (entacapone) in LCIG therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma concentration of levodopa without COMT inhibitor, with COMT inhibitor at 13 o'clock, or at 15 o'clock
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Entacapone 100mg
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Parkinson's disease who undergo LCIG therapy
Key exclusion criteria
Patients who have difficulty showing consent
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Hosokawa |
Organization
Ehime University Hospital
Division name
Department of Neurology and Clinical Pharmacology
Zip code
791-0295
Address
454, shitsukawa Tohon, Ehime, Japan
TEL
089-960-5095
hosokawa.yuko.ks@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Hosokawa |
Organization
Ehime University Hospital
Division name
Department of Neurology and Clinical Pharmacology
Zip code
791-0295
Address
454, shitsukawa Tohon, Ehime, Japan
TEL
089-960-5095
Homepage URL
hosokawa.yuko.ks@ehime-u.ac.jp
Sponsor or person
Institute
Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saiseikai Matsuyama Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board ,Ehime University Hospital
Address
Tohon, Ehime, Japan
Tel
089-960-5914
rinri@m.ehime-u.ac.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 | 07 | Month | 16 | 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 | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 16 | Day |
Last modified on
| 2019 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042629
