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
Verified date | June 2017 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The objective of this investigation is to collect following data in patients given NEXIUM capsule (NEXIUM) in usual post-marketing use.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Japan,
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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