Nexium Capsules S-CEI for Justification of Esomeprazole in Acid Related Disease for Reflux Symptom Healing Based on Patient Clinical Outcomes
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Conditions
Details and patient eligibility
About
The objective of this investigation is to collect following data in patients given NEXIUM capsule (NEXIUM) in usual post-marketing use.
Full 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
Enrollment
Sex
Volunteers
Inclusion criteria
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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
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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
Trial design
1,595 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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