UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021419 |
|---|---|
| Receipt number | R000024699 |
| Scientific Title | Investigation of adverse events in long-term administration of vonoprazan for patients with gastroesophageal reflux disease |
| Date of disclosure of the study information | 2016/03/10 |
| Last modified on | 2017/02/03 16:50:43 |
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Basic information
Public title
Investigation of adverse events in long-term administration of vonoprazan for patients with gastroesophageal reflux disease
Acronym
Investigation of adverse events in long-term administration of vonoprazan
Scientific Title
Investigation of adverse events in long-term administration of vonoprazan for patients with gastroesophageal reflux disease
Scientific Title:Acronym
Investigation of adverse events in long-term administration of vonoprazan
Region
| Japan |
Condition
Condition
Gastroesophageal reflux disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of adverse events in
long-term administration of vonoprazan for patients with gastroesophageal reflux disease.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of malignant tumor.
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with gastroesophageal reflux disease having possibility of taking vonoprazan for long-term.
Key exclusion criteria
The patients having contraindication of vonoprazan administratioon.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisatsugu Noda |
Organization
Aichi medical university school of medicine
Division name
gastroenterology
Zip code
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
bisaipan@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisatsugu Noda |
Organization
Aichi medical university school of medicine
Division name
gastroenterology
Zip code
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
Homepage URL
bisaipan@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi medical university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Aichi medical university school of medicine
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
| 2016 | Year | 03 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 03 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study
All the members who were equal to criteria for selection in the patients who consulted our institution in March, 2019 from March, 2016
Management information
Registered date
| 2016 | Year | 03 | Month | 10 | Day |
Last modified on
| 2017 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024699
