Gastroesophageal reflux disease (GERD)
Conditions
Interventions
None listed
Sponsors
GERD Society
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have provided written consent of their own free will to participate in the study after receiving sufficient written or verbal information about the study 2) Patients of both sexes aged 20 years or above. 3) Patients with heartburn or acid regurgitation of moderate or higher severity occurring at least once a week, or that of mild severity occurring at least twice a week, during the two weeks prior to the start of the study
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), or sudden weight loss 3) Patients with concurrent peptic ulcer (not in the scarring stage) 4) Patients with a prior or current history of any of the following diseases: - Zollinger-Ellison syndrome - Inflammatory bowel disease (IBD) - Irritable bowel syndrome (IBS) - Esophageal stricture - Eosinophilic reflux esophagitis - Esophageal achalasia - Malabsorption - Cerebrovascular disorders such as cerebral hemorrhage and cerebral infarction 5) Patients complicated by serious hepatic, renal, cardiac, or other diseases for which the participation in the study would be difficult 6) Patients with a confirmed or suspected malignant lesion 7) Patients who are pregnant, breastfeeding, or may be pregnant 8) Patients considered to require continued use of any drugs that could interact with the study drugs (i.e., atazanavir sulfate, diazepam, phenytoin, warfarin, tacrolimus hydrate, digoxin, methyldigoxin, itraconazole, gefitinib, voriconazole, antacids containing aluminium hydroxide gel and magnesium hydroxide, and clopidogrel) 9) Patients with a history of hypersensitivity to any components of proton pump inhibitor products 10) Patients who received a proton pump inhibitor or an H2-receptor antagonist within one week prior to enrollment in this study 11) Patients who underwent H. pylori eradication within six months prior to the start of the study 12) Patients with any concurrent disease interfering with normal living (e.g., psychiatric disease, poorly controlled metabolic disease, neurological disease, collagen disease) 13) Other patients judged by the physician to be inappropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Extent of involvement of individual background factors in the treatment response based on symptoms as measured using a patient questionnaire (GERD-TEST) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Differences in background factors between ERD patients and NERD patients (2) Responses of ERD and NERD to PPI therapy (3) Association between psychological bias and treatment response (4) Association between GERD-TEST and SF-8 (5) Association among individual parameters observed or measured | — |
Countries
Japan
Outcome results
None listed