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Completed

NCT Number: NCT02477475

Nexium Capsules S-CEI for 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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aichi, Japan

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About this study

Primary objective To investigate treatment response to NEXIUM in patients with reflux esophagitis (RE).

Secondary objectives

To investigate following items in patients with RE:

  • Patient satisfactory level of the treatment for RE
  • Health-related quality of life (HRQOL)
  • Severity and frequency of RE symptoms reported by physicians
  • Endoscopic healing rate
  • Development of ADRs

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients to be enrolled in this S-CEI must fulfill all the criteria below at the start of the treatment with NEXIUM.
  • Aged at least 20 years.
  • Patients who has a current or past history of clinically diagnosed RE
  • 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.
  • Patients to whom NEXIUM 20 mg once daily is to be administered for RE
  • 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:
  • Patients whose ability to follow instructions are suspected to be low by physicians
  • Patients with a past history of hypersensitivity to the ingredients of NEXIUM.
  • Patients receiving atazanavir sulfate or rilpivirine hydrochloride
  • Patients who have received NEXIUM within the past eight weeks for treatment of RE

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 22, 2015
Registry last updated
Jun 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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