UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022290 |
|---|---|
| Receipt number | R000025268 |
| Scientific Title | Comparison of acid inhibition attained by Vonoprazan with or without Lafutidine. |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2017/05/23 16:06:47 |
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Basic information
Public title
Comparison of acid inhibition attained by Vonoprazan with or without Lafutidine.
Acronym
Comparison of acid inhibition attained by Vonoprazan with or without Lafutidine.
Scientific Title
Comparison of acid inhibition attained by Vonoprazan with or without Lafutidine.
Scientific Title:Acronym
Comparison of acid inhibition attained by Vonoprazan with or without Lafutidine.
Region
| Japan |
Condition
Condition
Reflux esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare acid inhibitory effect of Vonoprazan and that with Lafutidine.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is acid inhibition with the three regimens as assessed by 24-hour intragastric pH monitoring on Day7 in each regimen.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
There are three regimens as follows; (1) Vonoprazan 20mg once daily for 7 days, (2) Vonoprazan 10mg once daily for 7 days, (3) Vonoprazan 10mg and Lafutidine 10mg once daily for 7 days. Subujects receive the three different regimens in a crossover manner. The order of the four regimens is randomized as interventions 1-24. Interventions 16-24 are mentioned in other related information, because of lack of the space.
A clinical research coordinator manages the dosing schedule of each subject. The washout period between the different regimens is at least 2 weeks. In each regimen, 24-h intragastric pH monitoring is performed on Day7.
Interventions 1; regimen (1), washout (at least 2 weeks), regimen (2), washout (at least 2 weeks), and regimen (3).
Interventions/Control_2
Interventions 2; regimen (1), washout (at least 2 weeks), regimen (3), washout (at least 2 weeks), and regimen (2).
Interventions/Control_3
Interventions 3; regimen (2), washout (at least 2 weeks), regimen (1), washout (at least 2 weeks), and regimen (3).
Interventions/Control_4
Interventions 4; regimen (2), washout (at least 2 weeks), regimen (3), washout (at least 2 weeks), and regimen (1).
Interventions/Control_5
Interventions 5; regimen (3), washout (at least 2 weeks), regimen (1), washout (at least 2 weeks), and regimen (2).
Interventions/Control_6
Interventions 6; regimen (3), washout (at least 2 weeks), regimen (2), washout (at least 2 weeks), and regimen (1).
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy Japanese men and women.
Key exclusion criteria
Exclusion criteria are any underlying disease, smoking habit, past or present H.pylori infection, and habitual use of any medicine.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Suzuki |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Medicine
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka, Japan
TEL
053-435-2111
takahr99@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahisa Furuta |
Organization
Hamamatsu University School of Medicine
Division name
Center for Clinical Research
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka, Japan
TEL
053-435-2261
Homepage URL
furuta@hama-med.ac.jp
Sponsor or person
Institute
First Department of Medicine and Center for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu, Japan
Institute
Department
Personal name
Funding Source
Organization
First Department of Medicine and Center for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu, Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
浜松医科大学(静岡県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | 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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 24 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 24 | Day |
Date trial data considered complete
| 2017 | Year | 02 | Month | 24 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 12 | Day |
Last modified on
| 2017 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025268
