UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030384 |
|---|---|
| Receipt number | R000034690 |
| Scientific Title | Effect of a New Potent Acid Inhibitory Drug, Vonoprazan on Healing Rate of Peptic Ulcers |
| Date of disclosure of the study information | 2017/12/20 |
| Last modified on | 2017/12/13 16:07:21 |
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Basic information
Public title
Effect of a New Potent Acid Inhibitory Drug, Vonoprazan on Healing Rate of Peptic Ulcers
Acronym
Effect of Vonoprazan on Healing Rate of Peptic Ulcers
Scientific Title
Effect of a New Potent Acid Inhibitory Drug, Vonoprazan on Healing Rate of Peptic Ulcers
Scientific Title:Acronym
Effect of Vonoprazan on Healing Rate of Peptic Ulcers
Region
| Japan |
Condition
Condition
Peptic Ulcers
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of a New Potent Acid Inhibitory Drug, Vonoprazan on Healing Rate of Peptic Ulcers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
to check the healing status of the peptic ulcers (gastric ulcer, 8 weeks after / duodenal ulcer, 6 weeks after)
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
the patients with peptic ulcers confirmed endoscopically
Key exclusion criteria
inpatient with another disease
a patient with the disease which has the risk of peptic ulcer
a patient who underwent GI tract operation before
malignant ulcer
ulcers located at duodenal 2nd portion
a patient who were administrated vonoprazan 20mg before
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeto Koizumi |
Organization
Akita University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-1-1, Hondo, Akita City, Akita, Japan
TEL
018-884-6104
shigeto@doc.med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeto Koizumi |
Organization
Akita University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-1-1, Hondo, Akita City, Akita, Japan
TEL
018-884-6104
Homepage URL
shigeto@doc.med.akita-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Akita University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2017 | Year | 12 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 25 | 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
study design: multicenter prospective observational study
to investigate the cause of the peptic ulcers before therapy, and to check the healing status of the peptic ulcers after administration of vonoprazan 20mg (gastric ulcer, 8 weeks after / duodenal ulcer, 6 weeks after)
Management information
Registered date
| 2017 | Year | 12 | Month | 13 | Day |
Last modified on
| 2017 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034690
