Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Digestive System Diseases+7

+ Duodenal Diseases

+ Esophageal Diseases

See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2015
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

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

Official TitleNEXIUM 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
NCT02477475
Principal SponsorAstraZeneca
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1595 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Digestive System DiseasesDuodenal DiseasesEsophageal DiseasesEsophagitisEsophagitis, PepticGastroenteritisGastrointestinal DiseasesIntestinal DiseasesPeptic UlcerStomach Diseases

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

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

Suspended

Research Site

Aichi, JapanOpen Research Site in Google Maps
Suspended

Research Site

Akita, Japan
Suspended

Research Site

Aomori, Japan
Suspended

Research Site

Chiba, Japan
Completed47 Study Centers