UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020989 |
|---|---|
| Receipt number | R000024230 |
| Scientific Title | Comparison of the effect of 20mg Vonoprazan,30mg,Lansoprazole and 20mg Famotidine on intragastric pH: A three-way crossover study |
| Date of disclosure of the study information | 2016/02/22 |
| Last modified on | 2018/02/14 15:29:29 |
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Basic information
Public title
Comparison of the effect of 20mg Vonoprazan,30mg,Lansoprazole and 20mg Famotidine on intragastric pH: A three-way crossover study
Acronym
Comparison of the effect of 20mg Vonoprazan,30mg,Lansoprazole and 20mg Famotidine on intragastric pH
Scientific Title
Comparison of the effect of 20mg Vonoprazan,30mg,Lansoprazole and 20mg Famotidine on intragastric pH: A three-way crossover study
Scientific Title:Acronym
Comparison of the effect of 20mg Vonoprazan,30mg,Lansoprazole and 20mg Famotidine on intragastric pH
Region
| Japan |
Condition
Condition
reflux esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The ideal medication for treatment of acid related diseases should have a rapid onset of action to promote hemostasis and symptoms.
No studies have compared directly the intragastric pH of Vonoprazan that is a new class of proton pomp inhibitor (PPI), Lansoprazole and Famotidine
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intragastric pH by pH meter attached to the antimony pH electrode for 6 hour after administration
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Vonoprazan20mg-(washout period)-Lansoprazole30mg-(washout period)-Famotidine20mg
Interventions/Control_2
Lansoprazole30mg-(washout period)-Vonoprazan20mg-(washout period)-Famotidine20mg
Interventions/Control_3
Famotidine20mg-(washout period)-Lansoprazole30mg-(washout period)-Vonoprazan20mg
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
Key inclusion criteria
Patient who fills everything the following
1) Helicobacter pylori-negative male Patient
2) Patient of 20 years or more
3) Patient who gives written informed consent
Key exclusion criteria
The patient who collides with either the following assumes that it doesn't put it in to the examination
1) Drug allergy
2) Patient who took medicine that influences movement and function of digestive tract such as proton pump inhibitor, H2 blocker, and NSAIDs within 4 weeks
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Inamori |
Organization
Yokohama City University School of Medicine
Division name
Department of Medical Education
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2626
inamorim@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Iida |
Organization
Yokohama City University School of Medicine
Division name
Department of Medical Education
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2800
Homepage URL
hiro0905@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University School of Medicine Department of Medical Education
Institute
Department
Personal name
Funding Source
Organization
None
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
横浜市立大学医学部
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 22 | 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 | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | 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 | 02 | Month | 12 | Day |
Last modified on
| 2018 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024230
