UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects on the pharmacokinetics of L-DOPA formulation by Proton pump inhibitors in patients with Parkinson's disease
Title of the study (Brief title)	Effects on the pharmacokinetics of L-DOPA formulation by Proton pump inhibitors 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	The aim of this study is to clarify the effect on the pharmacokinetics of L-DOPA formulation by Proton pump inhibitors in patients with Parkinson's disease, by the randomized, placebo-controlled, double-blind cross-over study
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	L-DOPA blood concentration in blood collection point of before taking L-DOPA formulation and study drug, and after taking 10,20,30,45,60,90,120,240 minutes
Key secondary outcomes	UPDRS part3 Symptom diary

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium10 Capsules(once a day 2Cap,after breakfast) Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium10 2Cap(20mg) Washout 6days 8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium Placebo Capsules(lactose,once a day 2Cap,after breakfast) Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium Placebo Capsules 2Cap
Interventions/Control_2	8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium Placebo Capsules(lactose,once a day 2Cap,after breakfast) Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium Placebo Capsules 2Cap Washout 6days 8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium10 Capsules(once a day 2Cap,after breakfast) Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium10 2Cap(20mg)
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1.Parkinson's patients with wearing-off phenomenon taking L-DOPA formulation, there are gastrointestinal symptoms, the test sharing doctor determines that it is necessary the administration of the new proton pump inhibitors 2.Patients signed informed consent 3.Male and female patients aged 20 to 85 years old 4.Hoeho and Yahr stages 2 to 4 degrees at the off-time 5.Patients who themselves can fill out the symptom diary 6.Patients takeing levodopa+carbidopa(Menesit100 Tablets or DopacolL100 Tablets) 7.Patients who don't have a prescription change of anti-Parkinson's disease drugs including the L-DOPA formulation, during the period from the observation period up to the end of the study 8.Patients who can stop taking entacapone-containing drugs,from the time of waking up until the test is finished in the blood concentration measurement date
Key exclusion criteria	1.Patients who can't take tablets and capsules 2.Patients after gastrectomy 3.Patients who are taking or within two weeks from final taking of H2-receptor antagonists and Proton pump inhibitors 4.Patients who need of administration of proton pump inhibitors in urgently 5.Patients with serious liver failure or renal dysfunction 6.Patients who have hypersensitivity to Nexium10 Capsules 7.Patients who take Combination contraindicated drugs with Nexium10 Capsules(Atazanavir Sulfate,Rilpivirine Hydrochloride) 8.Patients who have Lactose intolerance 9.Patients who are judged as unsuitable for the study by the investigator for the other reasons
Target sample size	8

Research contact person
Name of lead principal investigator	Munehiro Yoshino
Organization	Utano National Hospital, National Hospital Organization
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	Yuri Yoshimura
Organization	Utano National Hospital, National Hospital Organization
Division name	Department of Hospital Pharmacy
Address	8, Ondoyama, Narutaki, Ukyo-ku, Kyoto, Kyoto 616-8255
TEL	075-461-5121
Homepage URL
Email	y-yoshimura@unh.hosp.go.jp

Sponsor
Institute	Utano National Hospital, National Hospital Organization
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	2016 Year 06 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 04 Month 05 Day
Anticipated trial start date	2016 Year 06 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	2016 Year 05 Month 30 Day
Last modified on	2018 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025614