Nexium Capsules S-CEI for Justification of Esomeprazole in Acid Related Disease for Reflux Symptom Healing Based on Patient Clinical Outcomes

Overview

The objective of this investigation is to collect following data in patients given NEXIUM capsule (NEXIUM) in usual post-marketing use.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 20, 2017

Detailed Description

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

Arms, Groups and Cohorts

  • NEXIUM
    • Oral dose 20mg/day

Clinical Trial Outcome Measures

Primary Measures

  • Treatment response to NEXIUM based on answers in GerdQ
    • Time Frame: at the time of Treatment Week 8
    • The rate of patients whose answers in the GerdQ are “none” or “one day” in the questions Nos 1, 2, 5 and 6 at the end of the observation. GerdQ is a questionnaire for assessment of symptoms.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Shigeru Yoshida, MD, Study Director, AstraZeneca K.K.

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