To evaluate treatment efficacy after switching medication in reflux esophagitis patients who have parsistent gastro- esophageal reflux symptoms despite standard PPI therapy
- Conditions
- Gastroesophageal reflux disease
- Registration Number
- JPRN-UMIN000009398
- Lead Sponsor
- The Jikei University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 15
Not provided
(1)The patient has warning signs such as vomiting and gastrointestinal hemorrhage. (2)The patient needs to continue any drug that might interact with esomeprazole. (3)The patient previously had or currently has any of the following diseases. Zollinger-Ellison syndrome Esophageal stenosis Esophageal achalasia Cerebrovascular disorders such as cerebral hemorrhage and cerebral infarction (4)The patient has any serious hepatic, renal, or cardiac disease that makes participation in the study difficult in the opinion of the investigator. (5)The patient has a confirmed or suspected malignant lesion. (6)The patient is a pregnant, nursing, or possibly pregnant woman. (7)The patient is otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the FSSG score at Week 2 of esomeprazole treatment
- Secondary Outcome Measures
Name Time Method 1. Change in the FSSG score at Week 2 of esomeprazole treatment by pathological factor revealed through baseline 24-hr pH/MII monitoring (the change in the FSSG score will be evaluated for each of the following pathological factors) I. SI positive or negative II. Presence or absence of pathological acid reflux 2. Percentage of subjects with insufficient treatment response as confirmed by the GerdQ at Week 2 Percentage of subjects with gastroesophageal reflux symptoms at least 1 day per week at Week 2 3. Patient background factors that affect the change rate of the FSSG score after starting esomeprazole treatment