UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022529 |
|---|---|
| Receipt number | 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 14:01:31 |
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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
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
y-yoshimura@unh.hosp.go.jp
Sponsor or person
Institute
Utano National Hospital, National Hospital Organization
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025614
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