NCT02477475已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,595
- 试验地点
- 1
- 主要终点
- Treatment response to NEXIUM based on answers in GerdQ
研究概览
简要总结
The objective of this investigation is to collect following data in patients given NEXIUM capsule (NEXIUM) in usual post-marketing use.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Patients to whom NEXIUM 20 mg once daily is to be administered for RE
- •Patients from whom written consent has been obtained.
排除标准
- •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
结局指标
主要结局
Treatment response to NEXIUM based on answers in GerdQ
时间窗: 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.
次要结局
未报告次要终点
研究者
研究点 (1)
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