UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036494 |
|---|---|
| Receipt number | R000041582 |
| Scientific Title | Effect of drugs associated with gastric acid on concentration of levodopa preparations in Parkinson's disease |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2021/10/14 09:18:51 |
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Basic information
Public title
Effect of drugs associated with gastric acid on concentration of levodopa preparations in Parkinson's disease
Acronym
Effect of gastric acid on concentration of levodopa preparations in Parkinson's disease
Scientific Title
Effect of drugs associated with gastric acid on concentration of levodopa preparations in Parkinson's disease
Scientific Title:Acronym
Effect of drugs associated with gastric acid on concentration of levodopa preparations in Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between gastric acid and levodopa pereparations.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentration of levodopa preparations
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Discontinuance of taking medicine affecting gastric acid for 14 days
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with Parkinson's disease who take medicine affecting gastric pH
Key exclusion criteria
1. Patients with a history of gastrointestinal ulcers
2. Patients judged inappropriate with other reasons by investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Miyaue |
Organization
Saiseikai Matsuyama Hospital
Division name
Department of Neurology
Zip code
791-8026
Address
880-2, Yamanishi, Matsuyama, Ehime
TEL
089-951-6111
miyaue@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | MIyaue |
Organization
Saiseikai Matsuyama Hospital
Division name
Department of Neurology
Zip code
791-8026
Address
880-2, Yamanishi, Matsuyama, Ehime
TEL
089-951-6111
Homepage URL
miyaue@m.ehime-u.ac.jp
Sponsor or person
Institute
Saiseikai Matsuyama Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Matsuyama Hospital
Address
880-2, Yamanishi, Matsuyama, Ehime
Tel
089-960-5095
soumu@matsuyama.saiseikai.or.jp
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 13 | Day |
Last modified on
| 2021 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041582
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
