patients with reflux esophagitis
Conditions
Interventions
Sponsors
Japan Dyspepsia Society
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who have freely given written consent to participating in the study after receiving a full explanation (written and oral) of the study. (2) Patients of either sex who are at least 20 years of age. (3) Patients diagnosed endoscopically in the past 12 months with Grade A-D (Los Angeles classification) reflux esophagitis (4) Patients with a Global Overall Severity (GOS) score of ≥4 (troublesome to a moderate degree) for heartburn and/or acid regurgitation (sensation of gastric acid reflux) in the Epigastric Symptom Questionnaire
Exclusion criteria
Exclusion criteria: (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 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 anti-inflammatory 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time (number of days) to improvement in reflux symptoms after 1 week of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| . 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 | — |
Countries
Japan
Contacts
Public ContactYoshihide Kuremoto
Japan Dyspepsia Society Support Center Mebix, Inc, Department of Research Promotion
Outcome results
None listed