UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054409 |
|---|---|
| Receipt number | R000062057 |
| Scientific Title | Evaluation of the interaction between mirogabalin and proton pump inhibitors via renal tubular transporters |
| Date of disclosure of the study information | 2024/05/16 |
| Last modified on | 2024/05/16 11:06:18 |
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Basic information
Public title
Evaluation of the interaction between mirogabalin and proton pump inhibitors via renal tubular transporters
Acronym
Evaluation of the interaction between mirogabalin and proton pump inhibitors via renal tubular transporters
Scientific Title
Evaluation of the interaction between mirogabalin and proton pump inhibitors via renal tubular transporters
Scientific Title:Acronym
Evaluation of the interaction between mirogabalin and proton pump inhibitors via renal tubular transporters
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluating interactions between mirogabalin and proton pump inhibitors.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood concentration of mirogabalin on days 3 to 5 after administration
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
adult patients(Over 20 years old)receiving mirogabalin after thoracic surgery
Key exclusion criteria
(1) mirogabalin hypersensitivity, (2) patients who did not consent to participate in the study, (3) patients whose surgery was postponed, and (4) patients who deemed inappropriate by the physician
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Iwamoto |
Organization
Mie University Hospital
Division name
Department of Pharmacy
Zip code
514-8507
Address
2 174 Edobashi, Tsu city, Mie prefecture, JAPAN
TEL
059-232-1111
taku-iwa@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Hamaguchi |
Organization
Mie University Hospital
Division name
Department of Pharmacy
Zip code
514-8507
Address
2 174 Edobashi, Tsu city, Mie prefecture, JAPAN
TEL
059-232-1111
Homepage URL
naomi-h@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Mie University Hospital
Address
2 174 Edobashi, Tsu city, Mie prefecture, JAPAN
Tel
059-232-1111
naomi-h@med.mie-u.ac.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
| 2024 | Year | 05 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
82
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
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2024 | Year | 05 | Month | 16 | Day |
Last modified on
| 2024 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062057
