Unique ID issued by UMIN | UMIN000026407 |
---|---|
Receipt number | R000030339 |
Scientific Title | Study of symptom improvement effect of gastric acid suppressive drugs in reflux esophagitis patients with type 2 diabetes mellitus -a randomized comparative study of vonoprazan vs esomeprazole - |
Date of disclosure of the study information | 2017/03/06 |
Last modified on | 2018/09/11 15:51:58 |
Study of symptom improvement effect of gastric acid suppressive drugs in reflux esophagitis patients with type 2 diabetes mellitus
-a randomized comparative study of vonoprazan vs esomeprazole -
Study of symptom improvement effect of gastric acid suppressive drugs in reflux esophagitis patients with type 2 diabetes mellitus
-a randomized comparative study of vonoprazan vs esomeprazole -
Study of symptom improvement effect of gastric acid suppressive drugs in reflux esophagitis patients with type 2 diabetes mellitus
-a randomized comparative study of vonoprazan vs esomeprazole -
Study of symptom improvement effect of gastric acid suppressive drugs in reflux esophagitis patients with type 2 diabetes mellitus
-a randomized comparative study of vonoprazan vs esomeprazole -
Japan |
Reflux esophagitis with type 2 diabetes mellitus
Medicine in general |
Others
NO
To compare the clinical effect of vonoprazan 20mg/day vs. esomeprazole 20mg/day after 4 weeks of treatment in patients with reflux esophagitis with type 2 diabetes mellitus using GerdQ
Efficacy
Treatment response rate in the GerdQ
after 4 weeks of treatment.
Comparison of the effects of treatment between groups.
1) Complete resolution
rate in the GerdQ(heartburn, regurgitation) after 4 weeks of treatment.
Comparison of the effects of treatment between groups.
2) Change of GSRS score (average score, reflux syndrome, abdominal pain, constipation syndrome, diarrhea syndrome, indigestion syndrome) at 4 weeks after treatment.
3) Rate of change GSRS score (average score, reflux syndrome, abdominal pain, constipation syndrome, diarrhea syndrome, indigestion syndrome) .
Comparison of the effects of treatment between groups.
4)Sub analysis of treatment response
by patient demographics(including drugs, gender, age, BMI, Neuropathy).
5)Adverse event
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Vonoprazan 20mg orally once a day for 4 weeks
Esomeprazole 20mg orally once a day for 4 weeks
20 | years-old | <= |
80 | years-old | > |
Male and Female
1)Patients aged 20-79 years at the time of providing informed consent
2)Patients who are diagnosed as having reflux esophagitis by physician
3)Patients who scored 8 or above score in GerdQ
1)The patients with warning signs such as vomiting, gastrointestinal bleeding and sudden weight loss
2)The patients with confirmed or suspected malignant disease
3)The patients with a history of gastrointestinal resection or 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 hepatic, renal or heart disease
6)The pregnant patients or possibly pregnant patients
7)Patients unsuited for this study at a physician's discretion
8)Current treatment with gastric secretion inhibitors
9)Type 1 diabetes mellitus
40
1st name | |
Middle name | |
Last name | Takanori Kudo |
Hachinohe City Hospital
Department of Endocrinology and Diabetes
Tamukai aza bishamontaira 1, Hachinohe, Aomori
0178-72-5111
t-ku-do@pb3.so-net.ne.jp
1st name | |
Middle name | |
Last name | Takanori Kudo |
Hachinohe City Hospital
Department of Endocrinology and Diabetes
Tamukai aza bishamontaira 1, Hachinohe, Aomori
0178-72-5111
t-ku-do@pb3.so-net.ne.jp
Hachinohe City Hospital Department of Endocrinology and Diabetes
None
Self funding
NO
八戸市立市民病院(青森県)
2017 | Year | 03 | Month | 06 | Day |
Unpublished
Completed
2017 | Year | 01 | Month | 10 | Day |
2017 | Year | 03 | Month | 06 | Day |
2017 | Year | 03 | Month | 05 | Day |
2018 | Year | 09 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030339