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Recruitment status Terminated
Unique ID issued by UMIN UMIN000022529
Receipt No. R000025614
Scientific Title Effects on the pharmacokinetics of L-DOPA formulation by Proton pump inhibitors in patients with Parkinson's disease
Date of disclosure of the study information 2016/06/01
Last modified on 2018/06/16

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Basic information
Public title Effects on the pharmacokinetics of L-DOPA formulation by Proton pump inhibitors in patients with Parkinson's disease
Acronym Effects on the pharmacokinetics of L-DOPA formulation by Proton pump inhibitors in patients with Parkinson's disease
Scientific Title Effects on the pharmacokinetics of L-DOPA formulation by Proton pump inhibitors in patients with Parkinson's disease
Scientific Title:Acronym 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
1st name
Middle name
Last name Munehiro Yoshino
Organization Utano National Hospital, National Hospital Organization
Division name Department of Hospital Pharmacy
Zip code
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
1st name
Middle name
Last name Yuri Yoshimura
Organization Utano National Hospital, National Hospital Organization
Division name Department of Hospital Pharmacy
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Terminated
Date of protocol fixation
2016 Year 04 Month 05 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000025614

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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