Reflux esophagitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients who have given a written consent to participate in this study (2) Patients who were diagnosed as having erosive reflux esophagitis within six months before registration (3) Patients who have been receiving omeprazole 20mg per day for more than 8 weeks (4) Patient who can answer Frequency scale for symptoms of gastroesophageal reflux diseases (FSSG) questionnaire and Hospital Anxiety and Depression Scale (HADS) score
Exclusion criteria
Exclusion criteria: (1) Patients who have past history of or suffer from the following diseases: Zollinger-Ellison symdrome, inflammatory bowel disease, irritable bowel syndrome, achalasia, malabsorption (2) Patients with the past history of digestive tract excisio and vagotomy (3) Patients who have alert symptoms such as nausea, gastrointestinal bleeding and rapid weight loss (4) The patient who is complicated with peptic ulcer (gastric ulcer, duodenal ulcer) (5) Patients having severe liver, kidney or heart disease (6) Patients who have malignancy or are suspected of having malignancy (7) Patients who underwent Helicobacter pylori eradication within two months prior to the registration (8) Patients who are pregnant, breastfeeding, or may be pregnant (9) Patients who need continuous medication of atazanavir sulfate, digoxin, methyldigoxin, itraconazole, Gefinitinib or antacids containing aluminium hydroxide gel and magnesium hydroxide, that might interact with the test drug (10) Patients who are receiving H2 receptor blocker, prokinetic agent , gastroprotective agent, cholinolytic, antacid, antidepressant, antianxiety drug, steroid (except the agent for outside), bisphosphonate (11) Patients whom the doctor in charge judged to be unsuitable as an object of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Factors that may affect treatment with omeprazole 20mg/day for eight weeks (e.g.. age, gender, duration of GERD, H.pylori infection, hiatus hernia, and Hospital Anxiety and Depression Scale [HADS] score and Cyp2C19 genotype.) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Effect of symptom improvement after the administration of 20mg/day Omeprazole for eight weeks 2) Effect of symptom improvement after switching of 20mg/day Rabeprazole for 8 weeks | — |
Countries
Japan
Contacts
Internal Medicine, Osaka Medical College 2nd Department