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

June 20, 2017 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

1595

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aichi, Japan
        • Research Site
      • Akita, Japan
        • Research Site
      • Aomori, Japan
        • Research Site
      • Chiba, Japan
        • Research Site
      • Ehime, Japan
        • Research Site
      • Fukui, Japan
        • Research Site
      • Fukuoka, Japan
        • Research Site
      • Fukushima, Japan
        • Research Site
      • Gifu, Japan
        • Research Site
      • Gunma, Japan
        • Research Site
      • Hiroshima, Japan
        • Research Site
      • Hokkaido, Japan
        • Research Site
      • Hyogo, Japan
        • Research Site
      • Ibaraki, Japan
        • Research Site
      • Ishikawa, Japan
        • Research Site
      • Iwate, Japan
        • Research Site
      • Kagawa, Japan
        • Research Site
      • Kagoshima, Japan
        • Research Site
      • Kanagawa, Japan
        • Research Site
      • Kochi, Japan
        • Research Site
      • Kumamoto, Japan
        • Research Site
      • Kyoto, Japan
        • Research Site
      • Mie, Japan
        • Research Site
      • Miyagi, Japan
        • Research Site
      • Miyazaki, Japan
        • Research Site
      • Nagano, Japan
        • Research Site
      • Nagasaki, Japan
        • Research Site
      • Nara, Japan
        • Research Site
      • Niigata, Japan
        • Research Site
      • Oita, Japan
        • Research Site
      • Okayama, Japan
        • Research Site
      • Okinawa, Japan
        • Research Site
      • Osaka, Japan
        • Research Site
      • Saga, Japan
        • Research Site
      • Saitama, Japan
        • Research Site
      • Shiga, Japan
        • Research Site
      • Shimane, Japan
        • Research Site
      • Shizuoka, Japan
        • Research Site
      • Tochigi, Japan
        • Research Site
      • Tokushima, Japan
        • Research Site
      • Tokyo, Japan
        • Research Site
      • Tottori, Japan
        • Research Site
      • Toyama, Japan
        • Research Site
      • Wakayama, Japan
        • Research Site
      • Yamagata, Japan
        • Research Site
      • Yamaguchi, Japan
        • Research Site
      • Yamanashi, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Since the target patient population of the S-CEI is symptomatic RE patients, the patients fulfilling the inclusion criteria and not the exclusion criteria shown below will be enrolled as the subjects of this investigation.

Description

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

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
NEXIUM
Oral dose 20mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

at the time of Treatment Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2015

Primary Completion (Actual)

February 20, 2017

Study Completion (Actual)

February 20, 2017

Study Registration Dates

First Submitted

June 18, 2015

First Submitted That Met QC Criteria

June 19, 2015

First Posted (Estimate)

June 22, 2015

Study Record Updates

Last Update Posted (Actual)

June 21, 2017

Last Update Submitted That Met QC Criteria

June 20, 2017

Last Verified

June 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Reflux Esophagitis

3
Subscribe