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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000016659 |
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Date of registration:
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01/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparative study of the effects on L-dopa formulation absorption by the acid secretion inhibitor
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Scientific title:
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Comparative study of the effects on L-dopa formulation absorption by the acid secretion inhibitor - Comparative study of the effects on L-dopa formulation absorption by the acid secretion inhibitor |
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Date of first enrolment:
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2015/03/01 |
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Target sample size:
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3 |
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Recruitment status: |
Complete: follow-up continuing |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019181 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase I
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Countries of recruitment
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Japan
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Contacts
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Name:
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Kaho Yokoyama |
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Address:
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8, Ondoyama, Narutaki, Ukyo-ku, Kyoto, Kyoto 616-8255, Japan
Japan |
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Telephone:
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075-461-5121 |
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Email:
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caho-ish@unh.hosp.go.jp |
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Affiliation:
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Utano National Hospital, National Hospital Organaization Department of Hospital Pharmacy |
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Name:
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Hidemi Sunago |
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Address:
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8, Ondoyama, Narutaki, Ukyo-ku, Kyoto, Kyoto 616-8255, Japan
Japan |
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Telephone:
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075-461-5121 |
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Email:
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h-sunago@unh.hosp.go.jp |
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Affiliation:
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Utano National Hospital, National Hospital Organaization Department of Hospital Pharmacy |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Age minimum:
20years-old
Age maximum:
75years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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healty adult Parkinson's disease
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Intervention(s)
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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.)
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Primary Outcome(s)
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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
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Source(s) of Monetary Support
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None
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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