UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparative study of the effects on L-dopa formulation absorption by the acid secretion inhibitor
Title of the study (Brief title)	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	Hidemi Sunago
Organization	Utano National Hospital, National Hospital Organaization
Division name	Department of Hospital Pharmacy
Address	8, Ondoyama, Narutaki, Ukyo-ku, Kyoto, Kyoto 616-8255, Japan
TEL	075-461-5121
Email	h-sunago@unh.hosp.go.jp

Public contact
Name of contact person	Kaho Yokoyama
Organization	Utano National Hospital, National Hospital Organaization
Division name	Department of Hospital Pharmacy
Address	8, Ondoyama, Narutaki, Ukyo-ku, Kyoto, Kyoto 616-8255, Japan
TEL	075-461-5121
Homepage URL
Email	caho-ish@unh.hosp.go.jp

Sponsor
Institute	Utano National Hospital, National Hospital Organaization
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 01 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019181