UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022187 |
|---|---|
| Receipt number | R000025560 |
| Scientific Title | Research on Parkinson's disease pathogenesis based on analysis of caffeine absorption in patients with Parkinson's disease |
| Date of disclosure of the study information | 2016/05/06 |
| Last modified on | 2019/02/28 07:24:33 |
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Basic information
Public title
Research on Parkinson's disease pathogenesis based on analysis of caffeine absorption in patients with Parkinson's disease
Acronym
Analysis of caffeine absorption in patients with Parkinson's disease
Scientific Title
Research on Parkinson's disease pathogenesis based on analysis of caffeine absorption in patients with Parkinson's disease
Scientific Title:Acronym
Analysis of caffeine absorption in patients with Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detect the differences of caffeine absorption between Parkinson's disease and control.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
concentration changes of caffeine and its metabolites
(in serum of pre-administration and 0.5 h, 1 h, 2 h, 4 h and 6 h after administration of caffeine)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
PD group, 200 mg caffeine administration, qd, 1 day
Interventions/Control_2
Control group, 200 mg caffeine administration, qd, 1 day
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) 40-60 years old when the informed consent is obtained.
2) Clinical stage: Hoehn and Yahr I or II
3) After having sufficient explanation, he/she agreed with joining in this research with his/her own informed consent form.
Key exclusion criteria
1) >= 24 in Mini Mental State Examinations
2) Without heart disease, glaucoma or peptic ulcer.
3) Positive to past history of gasterointestinal surgery.
4) Presently having inflammatory bowel diseases, collagen vascular diseases, or bronchial asthma.
5) Having oral contraceptives.
6) Difficulty in withdraw caffeine intake just during 3 days before caffeine administration.
7) inappropriate cases who principle investigator identified.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobutaka Hattori |
Organization
Juntendo University
Division name
Department of Neurology
Zip code
Address
2-1-1 Hongo Bunkyo
TEL
81-3-3813-3111
nhattori@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Saiki |
Organization
Juntendo University
Division name
Department of Neurology
Zip code
Address
2-1-1
TEL
81-3-3813-3111
Homepage URL
ssaiki@juntendo.ac.jp
Sponsor or person
Institute
Department of Neurology, Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
順天堂大学医学部附属順天堂医院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 06 | 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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 02 | Day |
Last modified on
| 2019 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025560
