Nexium Capsules S-CEI for Justification of Esomeprazole in Acid Related Disease for Reflux Symptom Healing Based on Patient Clinical Outcomes
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
1 other identifier
observational
1,595
1 country
47
Brief Summary
The objective of this investigation is to collect following data in patients given NEXIUM capsule (NEXIUM) in usual post-marketing use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2015
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2015
CompletedFirst Posted
Study publicly available on registry
June 22, 2015
CompletedStudy Start
First participant enrolled
July 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2017
CompletedJune 21, 2017
June 1, 2017
1.6 years
June 18, 2015
June 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
NEXIUM
Oral dose 20mg/day
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (47)
Research Site
Aichi, Japan
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Akita, Japan
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Aomori, Japan
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Chiba, Japan
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Ehime, Japan
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Fukui, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Gifu, Japan
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Gunma, Japan
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Hiroshima, Japan
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Hokkaido, Japan
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Hyōgo, Japan
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Ibaraki, Japan
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Ishikawa, Japan
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Kagawa, Japan
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Kagoshima, Japan
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Kanagawa, Japan
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Kochi, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Mie, Japan
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Miyagi, Japan
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Miyazaki, Japan
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Nagano, Japan
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Nagasaki, Japan
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Nara, Japan
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Niigata, Japan
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Numakunai, Japan
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Okayama, Japan
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Okinawa, Japan
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Osaka, Japan
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Ōita, Japan
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Saga, Japan
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Saitama, Japan
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Shiga, Japan
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Shimane, Japan
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Shizuoka, Japan
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Tochigi, Japan
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Tokushima, Japan
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Tokyo, Japan
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Tottori, Japan
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Toyama, Japan
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Wakayama, Japan
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Yamagata, Japan
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Yamaguchi, Japan
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Yamanashi, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shigeru Yoshida, MD
AstraZeneca
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2015
First Posted
June 22, 2015
Study Start
July 7, 2015
Primary Completion
February 20, 2017
Study Completion
February 20, 2017
Last Updated
June 21, 2017
Record last verified: 2017-06