UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025238 |
|---|---|
| Receipt number | R000029029 |
| Scientific Title | A study on evaluation gastric acid pocket by vertical 8 channel pH monitoring system and the effect of vonoprazan on gastric acid pocket |
| Date of disclosure of the study information | 2016/12/13 |
| Last modified on | 2016/12/12 20:18:00 |
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Basic information
Public title
A study on evaluation gastric acid pocket by vertical 8 channel pH monitoring system and the effect of vonoprazan on gastric acid pocket
Acronym
Evaluation of gastric acid pocket by 8ch pH monitoring system
Scientific Title
A study on evaluation gastric acid pocket by vertical 8 channel pH monitoring system and the effect of vonoprazan on gastric acid pocket
Scientific Title:Acronym
Evaluation of gastric acid pocket by 8ch pH monitoring system
Region
| Japan |
Condition
Condition
Gastroesophageal reflux disease
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We use vertical 8 channelpH monitoring system and evaluate acid pocket,which is high acidity layer in stomach after meal.
Next we evaluate the effect of vonoprazan to acid pocket.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
acid pocket size and formation time
Key secondary outcomes
Acid pocket size and change in formation time,adverse event after administering vonoprazan,
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administer bonoprazan
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
1.Healthy adult over 20-year-old
2.Helicobacter pylori negative
3. Agreement from subjects about this study
Key exclusion criteria
1.Lidocaine or Anilide type local anesthetic Allergies
2.Gastrointestinal resection or
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | shohei sumi |
Organization
shimane university hospital
Division name
department of gastroenterology
Zip code
Address
89-1 Enya-cho,Izumo city,Shimane pref,693-8501,Japan
TEL
0853-20-2190
sumi@med.shimane.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | shohei sumi |
Organization
shimane university hospital
Division name
department of gastroenterology
Zip code
Address
89-1 Enya-cho,Izumo city,Shimane pref,693-8501,Japan
TEL
0853-20-2190
Homepage URL
sumi@med.shimane.ac.jp
Sponsor or person
Institute
Shimane university
Institute
Department
Personal name
Funding Source
Organization
Shimane university
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
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
| 2016 | Year | 12 | Month | 13 | 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
Date of protocol fixation
| 2016 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | 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 | 12 | Month | 12 | Day |
Last modified on
| 2016 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029029
