Clinical Trial: Nexium Capsules S-CEI for Justification of Esomeprazole in Acid Related Disease for Reflux Symptom Healing Based on Patient Clinical Outcomes
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: NEXIUM Capsule Specific Clinical Experience Investigation (S-CEI) to Investigate Treatment Response to NEXIUM in Patients With Reflux Esophagitis (RE) - Justification of E
Brief Summary: The objective of this investigation is to collect following data in patients given NEXIUM capsule (NEXIUM) in usual post-marketing use.
Detailed Summary:
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
Sponsor: AstraZeneca
Current Primary Outcome: Treatment response to NEXIUM based on answers in GerdQ [ Time Frame: 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.
Original Primary Outcome: The rate of patients whose answers in the GerdQ are "none" or "one day" in the questions Nos 1, 2, 5 and 6 [ Time Frame: at the time of Treatment Week 8 ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: AstraZeneca
Dates:
Date Received: June 18, 2015
Date Started: July 7, 2015
Date Completion:
Last Updated: March 21, 2017
Last Verified: March 2017