Study of the improvement effect of potassium competitive acid blocker and proton pump inhibitors on symptoms in patients with gastro-esophageal reflux disease (GERD): a randomized comparative study of vonoprazan 20mg vs. rabeprazole 10mg using the time (number of days) to improvement in symptoms as an index
- Conditions
- gastro-esophageal reflux disease (GERD)
- Registration Number
- JPRN-UMIN000021621
- Lead Sponsor
- Department of Gastroenterology, Juntendo University School of Medicine, Tokyo, Japan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 100
Not provided
(1)Patients with a history of gastrointestinal resection or vagotomy (2)Patients with warning signs such as vomiting, gastrointestinal bleeding (including findings of hematemesis, melena, and anemia),and sudden weight loss (3)Patients with peptic ulcer (except those in scarring stage) (4)Patients with a history of, or who currently have, any of the following diseases Zollinger-Ellison syndrome Inflammatory Bowel Disease (IBD) Irritable Bowel Syndrome (IBS) Esophageal stricture Esophageal achalasia Malabsorption Cerebrovascular disorders such as cerebral hemorrhage and cerebral infarction (5)Patients whose participation in this study would be contraindicated due to complications such as serious hepatic disease, renal disease, or cardiac disease. (6)Patients with a confirmed, or suspected, malignant lesion (7)Women who are pregnant or who may possibly be pregnant, and lactating mothers (8)Patients who require continued treatment with drugs (atazanavir sulfate, diazepam, phenytoin, warfarin, tacrolimus hydrate, digoxin, methyldigoxin, itraconazole, gefitinib, voriconazole, and antacids containing aluminium hydroxide gel and magnesium hydroxide) which may interact with the study drugs (9)Patients receiving treatment with potassium competitive acid blocker, proton pump inhibitors, H2-receptor antagonists, prokinetic agents, gastric mucosa protective agents, anticholinergics, antacids, antidepressants, antianxiety agents, antidiabetic drugs, steroids (excluding external preparations), non-steroid antiinflammatory drugs (NSAIDs), aspirin preparations including low-dose aspirin and/or bisphosphonate drugs. However, patients who discontinue using these drugs for at least 1 week prior to the symptom survey or switch to another treatment, may enrol in the study. (10)Other patients whom the investigator considers unsuitable for admission to the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time (number of days) to improvement in reflux symptoms after 1 week of treatment
- Secondary Outcome Measures
Name Time Method i Change in reflux symptom score after treatment ii. Improvement rates in reflux symptoms after 2 and 4 weeks of treatment iii. Frequency of heartburn, acid regurgitation (sensation of gastric acid reflux), stomach pain, heavy stomach feeling, early satiety, nausea, burping, and bloating in subjects prior to treatment assignment iv. Improvement rate in individual symptoms after 2 and 4 weeks of treatment v. Improvement rate in overall symptoms after 2 and 4 weeks of treatment vi. Factors such as patient background and morbidity period which affect change in score after treatment