UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031632 |
|---|---|
| Receipt number | R000036111 |
| Scientific Title | Development of acid inhibition without hypergastrinemia |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2019/02/21 17:51:10 |
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Basic information
Public title
Development of acid inhibition without hypergastrinemia
Acronym
Development of acid inhibition
Scientific Title
Development of acid inhibition without hypergastrinemia
Scientific Title:Acronym
Development of acid inhibition
Region
| Japan |
Condition
Condition
Hypergastrinemia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of safety and effective acid inhibition therapy without hypergastrinemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intragastric pH
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
VPZ 10mg/day
Interventions/Control_2
LAF 10mg x 2/day
Interventions/Control_3
PIR 25mg x 3/day
Interventions/Control_4
VPZ 10mg/day plus LAF 10mg x 2/day
Interventions/Control_5
VPZ 10mg/day plus PIR 25mg x 3/day
Interventions/Control_6
VPZ 10mg/day plus LAF 10mg x 2/day plus PIR 25mg x 3/day
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The H.pylori naive candidate without medication in recent one month
Key exclusion criteria
1.The candidate with past history
2.The candidate with pregnancy or breast-feeding
3.Smoker
4.The candidate without allowance of Medical Docter
Target sample size
40
Research contact person
Name of lead principal investigator
| 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 431-3192, Japan
TEL
053-435-2261
furuta@hama-med.ac.jp
Public contact
Name of contact person
| 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 431-3192, Japan
TEL
053-435-2261
Homepage URL
takahr99@hama-med.ac.jp
Sponsor or person
Institute
First Department of Medicine, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | 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
| 2018 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | 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
| 2018 | Year | 03 | Month | 07 | Day |
Last modified on
| 2019 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036111
