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NCT02477475 Clinical Trial

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

Reflux Esophagitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02477475
Other study ID # D961HL00020
Secondary ID
Status Completed
Phase N/A
First received June 18, 2015
Last updated June 20, 2017
Start date July 7, 2015
Est. completion date February 20, 2017

Study information
Verified date June 2017
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 1595
Est. completion date February 20, 2017
Est. primary completion date February 20, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Research Site 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

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment response to NEXIUM based on answers in GerdQ 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
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