- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02477475
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
Study Overview
Status
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:
- 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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aichi, Japan
- Research Site
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Akita, Japan
- Research Site
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Aomori, Japan
- Research Site
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Chiba, Japan
- Research Site
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Ehime, Japan
- Research Site
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Fukui, Japan
- Research Site
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Fukuoka, Japan
- Research Site
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Fukushima, Japan
- Research Site
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Gifu, Japan
- Research Site
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Gunma, Japan
- Research Site
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Hiroshima, Japan
- Research Site
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Hokkaido, Japan
- Research Site
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Hyogo, Japan
- Research Site
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Ibaraki, Japan
- Research Site
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Ishikawa, Japan
- Research Site
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Iwate, Japan
- Research Site
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Kagawa, Japan
- Research Site
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Kagoshima, Japan
- Research Site
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Kanagawa, Japan
- Research Site
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Kochi, Japan
- Research Site
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Kumamoto, Japan
- Research Site
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Kyoto, Japan
- Research Site
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Mie, Japan
- Research Site
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Miyagi, Japan
- Research Site
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Miyazaki, Japan
- Research Site
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Nagano, Japan
- Research Site
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Nagasaki, Japan
- Research Site
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Nara, Japan
- Research Site
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Niigata, Japan
- Research Site
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Oita, Japan
- Research Site
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Okayama, Japan
- Research Site
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Okinawa, Japan
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Osaka, Japan
- Research Site
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Saga, Japan
- Research Site
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Saitama, Japan
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Shiga, Japan
- Research Site
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Shimane, Japan
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Shizuoka, Japan
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Tochigi, Japan
- Research Site
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Tokushima, Japan
- Research Site
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Tokyo, Japan
- Research Site
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Tottori, Japan
- Research Site
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Toyama, Japan
- Research Site
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Wakayama, Japan
- Research Site
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Yamagata, Japan
- Research Site
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Yamaguchi, Japan
- Research Site
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Yamanashi, Japan
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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.
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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NEXIUM
Oral dose 20mg/day
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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
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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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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D961HL00020
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.
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