NEXIUM Capsule Specific Clinical Experience Investigation (S-CEI) to Investigate Treatment Response to NEXIUM in Patients With Reflux Esophagitis (RE) - Justification of Esomeprazole in Acid Related Disease for Reflux Symptom Healing Based on Patient Clinical Outcomes
Data Collection
Collected from today forward - ProspectiveDigestive System Diseases+7
+ Duodenal Diseases
+ Esophageal Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: July 7, 2015
Actual date on which the first participant was enrolled.Primary objective To investigate treatment response to NEXIUM in patients with reflux esophagitis (RE). Secondary objectives To investigate following items in patients with RE: 1. Patient satisfactory level of the treatment for RE 2. Health-related quality of life (HRQOL) 3. Severity and frequency of RE symptoms reported by physicians 4. Endoscopic healing rate 5. Development of ADRs
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1595 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Patients to be enrolled in this S-CEI must fulfill all the criteria below at the start of the treatment with NEXIUM. 1. Aged at least 20 years. 2. Patients who has a current or past history of clinically diagnosed RE 3. Patients whose answers in the baseline GerdQ include "2-3 days" or "4-7 days" in at least one of the questions Nos 1, 2, 5 and 6. 4. Patients to whom NEXIUM 20 mg once daily is to be administered for RE 5. Patients from whom written consent has been obtained. Exclusion Criteria: * Patients must not enter the investigation if any of the following exclusion criteria are fulfilled at the start of the treatment with NEXIUM: 1. Patients whose ability to follow instructions are suspected to be low by physicians 2. Patients with a past history of hypersensitivity to the ingredients of NEXIUM. 3. Patients receiving atazanavir sulfate or rilpivirine hydrochloride 4. Patients who have received NEXIUM within the past eight weeks for treatment of RE
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 47 locations
Research Site
Akita, JapanResearch Site
Aomori, JapanResearch Site
Chiba, Japan