UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026250 |
|---|---|
| Receipt number | R000030152 |
| Scientific Title | Symptom relief of gastric acid suppressants in patients with reflux esophagitis - Randomized controlled comparative study of vonoprazan and esomeprazole - |
| Date of disclosure of the study information | 2017/02/23 |
| Last modified on | 2017/04/06 14:15:13 |
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Basic information
Public title
Symptom relief of gastric acid suppressants in patients with reflux esophagitis
- Randomized controlled comparative study of vonoprazan and esomeprazole -
Acronym
Symptom relief of gastric acid suppressants in patients with reflux esophagitis
Scientific Title
Symptom relief of gastric acid suppressants in patients with reflux esophagitis
- Randomized controlled comparative study of vonoprazan and esomeprazole -
Scientific Title:Acronym
Symptom relief of gastric acid suppressants in patients with reflux esophagitis
Region
| Japan |
Condition
Condition
Reflex esophagitis patients
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate GERD related symptom relief of vonoprazan and esomeprazole
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sufficient relief of GERD symptom Change of total score of heartburn and regurgitation evaluated by GOS Questionnaire after 4,8-week treatment
Key secondary outcomes
1:The Change of individual score and the improvement of symptom (heartburn, regurgitation) evaluated using GOS /FSSG after 4,8-week treatment
2:The improvement of symptom (epigastric pain, nausea, vomiting) evaluated using GOS /FSSG after 4,8-week treatment
3:Treatment response evaluated by GOS /FSSG after 4,8-week treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Vonoprazan 20mg p.o. once daily, 4weeks,and Vonoprazan 10mg p.o. once daily, 4weeks
Interventions/Control_2
Esomeprazole 20mg p.o. once daily, 4,8-weeks
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:Patients who have freely provided written informed consent for the participation of this study after the oral or written sufficient explanation.
2:Patients who were confirmed reflux esophagitis with grade A-D of LA classification at the entry or in the past.
3:Patients who answered score of 4 (moderate problem) or severer in questions about heartburn, Q2 and/or regurgitation, Q3.
Key exclusion criteria
1:Patients with warning signs such as vomiting, gastrointestinal bleeding and sudden weight loss.
2:Patients with confirmed or suspected malignant diseases.
3:Patients with a history of gastrointestinal resection of vagotomy.
4:Patients with a history of irritable bowel syndrome.
5:Patients whose participation in this study would be contraindicated due to complications such as serious hepatic, renal or heart disease.
6:Pregnant patients, possibly pregnant or lactating women.
7:Patients judged as inadequate in participation of this study by their attending physicians.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Hirano |
Organization
Hirano Gastroenterology Clinic
Division name
Gastroenterology
Zip code
Address
2-3029-2,Onuki town, Nobeoka city, Miyazaki prefecture
TEL
0982-26-7070
gihirano@gaea.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Hirano |
Organization
Hirano Gastroenterology Clinic
Division name
Gastroenterology
Zip code
Address
2-3029-2,Onuki town, Nobeoka city, Miyazaki prefecture
TEL
0982-26-7070
Homepage URL
gihirano@gaea.ocn.ne.jp
Sponsor or person
Institute
Hirano Gastroenterology Clinic
Institute
Department
Personal name
Funding Source
Organization
Hirano Gastroenterology 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
平野消化器科
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 23 | 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 | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 06 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 06 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 06 | Day |
Date analysis concluded
| 2017 | Year | 04 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 21 | Day |
Last modified on
| 2017 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030152
