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
Not Applicable
- Conditions
- Reflux esophagitis with type 2 diabetes mellitus
- Registration Number
- JPRN-UMIN000026407
- Lead Sponsor
- Hachinohe City Hospital Department of Endocrinology and Diabetes
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment response rate in the GerdQ after 4 weeks of treatment. Comparison of the effects of treatment between groups.
- Secondary Outcome Measures
Name Time Method 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