Unique ID issued by UMIN | UMIN000027069 |
---|---|
Receipt number | R000031032 |
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 | 2017/04/20 |
Last modified on | 2017/04/19 20:12:05 |
Symptom relief of gastric acid suppressants in patients with reflux esophagitis
- Randomized controlled comparative study of vonoprazan and esomeprazole -
Symptom relief of gastric acid suppressants in patients with reflux esophagitis
Symptom relief of gastric acid suppressants in patients with reflux esophagitis
- Randomized controlled comparative study of vonoprazan and esomeprazole -
Symptom relief of gastric acid suppressants in patients with reflux esophagitis
Japan |
Reflex esophagitis patients
Hepato-biliary-pancreatic medicine |
Others
NO
To evaluate GERD related symptom relief of vonoprazan and esomeprazole
Efficacy
Confirmatory
Pragmatic
Not applicable
GOS Questionnaire after 84-week treatment
1:The Change of individual score and the improvement of symptom (heartburn,regurgitation) evaluated using GOS/FSSG after4,8-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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Vonoprazan 20mg p.o. once daily, 4weeks,and Vonoprazan 10mg p.o. once daily, 4weeks
Esomeprazole 20mg p.o. once daily, 8weeks
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
60
1st name | |
Middle name | |
Last name | Masahiro Hirano |
Hirano Gastroenterology Clinic
Gastroenterology
2-3029-2,Onuki town, Nobeoka city, Miyazaki prefecture
0982-26-7070
gihirano@gaea.ocn.ne.jp
1st name | |
Middle name | |
Last name | Masahiro Hirano |
Hirano Gastroenterology Clinic
Gastroenterology
2-3029-2,Onuki town, Nobeoka city, Miyazaki prefecture
0982-26-7070
gihirano@gaea.ocn.ne.jp
Hirano Gastroenterology Clinic
Hirano Gastroenterology Clinic
Self funding
NO
平野消化器内科(Hirano Gastroenterology Clinic)
2017 | Year | 04 | Month | 20 | Day |
Unpublished
Open public recruiting
2017 | Year | 01 | Month | 01 | Day |
2017 | Year | 01 | Month | 04 | Day |
2017 | Year | 04 | Month | 19 | Day |
2017 | Year | 04 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031032