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

Completed

• Conditions: Reflux Esophagitis

• Registration Number: NCT02477475
• Lead Sponsor: AstraZeneca

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-06-18
• Study First Submitted QC: 2015-06-19
• Study First Posted: 2015-06-22
• Study Start: 2015-07-07
• Primary Completion: 2017-02-20
• Study Completion: 2017-02-20
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-20
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1595

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment response to NEXIUM based on answers in GerdQ	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.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yamanashi, Japan