Reflux esophagitis
Conditions
Interventions
Sponsors
Eligibility
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 who have moderate or severe degree of day-time and night-time heartburn at least once a week prior to treatment
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 under atazanavir sulfate administration (9) Patients receiving treatment with proton pump inhibitors, H2-receptor antagonists, prokinetic agents, gastric mucosa protective agents, anticholinergics, antidepressants, antianxiety agents, steroids (excluding external preparations), non-steroid anti-inflammatory drugs (NSAIDs), aspirin preparations including low-dose aspirin,anticoagulant drugs and bisphosphonate drugs in the past 2 week prior to treatment. (10) Other patients whom the investigator considers unsuitable for admission to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of symptom score in day-time and night-time heartburn during 1 week of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Percentage of patientss who achieve complete relief in day-time and night-time heartburn during 1 week of treatment (2) Change of symptom score in sleep disorder during 1 week of treatment (3) Change of symptom score in day-time and night-time heartburn during 1 week of treatment according to severity before treatment | — |
Countries
Japan
Contacts
Juntendo University School of Medicine Department of Gastroenterology and Hepatology