A fact-finding study on the treatment of gastroesophageal reflux disease (GERD) -Investigation of response to proton pump inhibitor (PPI) therapy and factors involved
- Conditions
- Gastroesophageal reflux disease (GERD)
- Registration Number
- JPRN-UMIN000006614
- Lead Sponsor
- GERD Society
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 500
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), 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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method