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 -

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026407

Enrollment

Registered

2017-03-06

Start date

2017-03-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reflux esophagitis with type 2 diabetes mellitus

Interventions

Vonoprazan 20mg orally once a day for 4 weeks Esomeprazole 20mg orally once a day for 4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

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 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

Design outcomes

Primary

Measure	Time frame
Treatment response rate in the GerdQ after 4 weeks of treatment. Comparison of the effects of treatment between groups.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactTakanori Kudo

Hachinohe City Hospital Department of Endocrinology and Diabetes

t-ku-do@pb3.so-net.ne.jp0178-72-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026