Nexium Capsules S-CEI for Justification of Esomeprazole in Acid Related Disease for Reflux Symptom Healing Based on Patient Clinical Outcomes

Launched by ASTRAZENECA · Jun 19, 2015

Keywords

ClinConnect 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:

1. Patient satisfactory level of the treatment for RE
2. Health-related quality of life (HRQOL)
3. Severity and frequency of RE symptoms reported by physicians
4. Endoscopic healing rate
5. Development of ADRs

Gender

ALL

Eligibility criteria

• 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