UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016659 |
|---|---|
| Receipt number | R000019181 |
| Scientific Title | Comparative study of the effects on L-dopa formulation absorption by the acid secretion inhibitor |
| Date of disclosure of the study information | 2015/03/01 |
| Last modified on | 2018/03/01 13:44:25 |
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Basic information
Public title
Comparative study of the effects on L-dopa formulation absorption by the acid secretion inhibitor
Acronym
Comparative study of the effects on L-dopa formulation absorption by the acid secretion inhibitor
Scientific Title
Comparative study of the effects on L-dopa formulation absorption by the acid secretion inhibitor
Scientific Title:Acronym
Comparative study of the effects on L-dopa formulation absorption by the acid secretion inhibitor
Region
| Japan |
Condition
Condition
healty adult
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is clarify the effect in absorption of L-dopa formulation by taking with acid secretion inhibitor, and the difference in effect on H2-receptor antagonists and Proton pump inhibitors
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
L-dopa blood concentration in blood collection point of taking L-dopa formulation before, after taking 10,20,30,60,120,240 minutes when taking L-dopa formulation alone, combination with H2-receptor antagonists, combination with Proton pump inhibitors
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
MENESIT100 1tablet once a day (p.o.)
famotidine 40mg/day for previous 1day (p.o.)
MENESIT100 1tablet once a day (p.o.)
esomeprazole 20mg for previous three days or more (p.o.)
MENESIT100 1tablet once a day (p.o.)
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Subjects gave consent in writing
2.Subjects between 20 and 75 year of age at the time of obtaining informed consent
Key exclusion criteria
1.Subjects taking H2-receptor antagonists and Proton pump inhibitors
2.Subjects with allergy for L-dopa formulation,H2-receptor antagonists and Proton pump inhibitors
3.Subjects taking drugs that have interaction with L-dopa formulation,H2-receptor antagonists and Proton pump inhibitors
4.Subjects with glaucoma
5.Subjects with liver failure or renal dysfunction
6.Subjects with gastric ulcer,duodenal ulcer or with that history
7.Diabetic
8.Subjects with serious lung disease, serious cardiovascular disease,bronchial asthma or endocrine disorder
9.Subjects with psychiatric symptoms such as suicidal tendencies
10.Dialysis patient
11.Pregnant women or women who may possibly be pregnant
12.Subjects who are judged to be inadequate to participate in this trial at the blood sampling of provisional registration
13.Others, subjects who are judged to be inadequate to participate in this trial
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidemi Sunago |
Organization
Utano National Hospital, National Hospital Organaization
Division name
Department of Hospital Pharmacy
Zip code
Address
8, Ondoyama, Narutaki, Ukyo-ku, Kyoto, Kyoto 616-8255, Japan
TEL
075-461-5121
h-sunago@unh.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaho Yokoyama |
Organization
Utano National Hospital, National Hospital Organaization
Division name
Department of Hospital Pharmacy
Zip code
Address
8, Ondoyama, Narutaki, Ukyo-ku, Kyoto, Kyoto 616-8255, Japan
TEL
075-461-5121
Homepage URL
caho-ish@unh.hosp.go.jp
Sponsor or person
Institute
Utano National Hospital, National Hospital Organaization
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
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
独立行政法人国立病院機構宇多野病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 27 | Day |
Last modified on
| 2018 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019181
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
