UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028962 |
|---|---|
| Receipt number | R000033145 |
| Scientific Title | Comparative study of symptom improvement effect of vonoprazan and esomeprazole in patients with reflux esophagitis. |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2017/09/01 17:43:21 |
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Basic information
Public title
Comparative study of symptom improvement effect of vonoprazan and esomeprazole in patients with reflux esophagitis.
Acronym
Study of symptom improvement effect of gastric secretion inhibitors in patients with reflux esophagitis.
Scientific Title
Comparative study of symptom improvement effect of vonoprazan and esomeprazole in patients with reflux esophagitis.
Scientific Title:Acronym
Study of symptom improvement effect of gastric secretion inhibitors in patients with reflux esophagitis.
Region
| Japan |
Condition
Condition
Reflex esophagitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical symptom improvement effect of Vonoprazan compared with esomeprazole
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of total score evaluated using FSSG
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Vonoprazan 20mg oral once a day, 4weeks
Interventions/Control_2
Esomeprazole 20mg oral once a day, 4weeks
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.The patients aged 20 years or older.
2.The patients who are diagnosed as having reflux esophagitis by physician.
3.The patients who have GERD symptom (heartburn or acid regurgitation) at least once a week.
Key exclusion criteria
1.The patients with warning signs such as vomiting, gastrointestinal bleeding and sudden weight loss.
2.The patients with confirmed or suspected malignant diseases.
3.The patients with a history of gastrointestinal resection of vagotomy.
4.The patients with a history of irritable bowel syndrome.
5.The patients whose participation in this study would be contraindicated due to complications such as serious heaptic, renal or heart disease.
6.The Pregnant patients or possibly pregnant patients.
7.The patients prohibited the participant of this study by their attending physicians.
8.The patients who took esomeprazole or vonoprazan within 4 weeks.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Masuda |
Organization
Ikoma Gastorenteroproctorogy Clinic
Division name
Gastroenterology
Zip code
Address
7-10 Honmachi, Ikoma-shi, Nara
TEL
0743-71-8050
t-masuda@gaia.eonet.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Masuda |
Organization
Ikoma Gastorenteroproctorogy Clinic
Division name
Gastroenterology
Zip code
Address
7-10 Honmachi, Ikoma-shi, Nara
TEL
0743-71-8050
Homepage URL
t-masuda@gaia.eonet.ne.jp
Sponsor or person
Institute
Ikoma Gastorenteroproctorogy Clinic
Institute
Department
Personal name
Funding Source
Organization
Ikoma Gastorenteroproctorogy Clinic
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
| 2017 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | 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
| 2017 | Year | 09 | Month | 01 | Day |
Last modified on
| 2017 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033145
