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Fexuclue for Prevention of NSAIDs-Induced Peptic Ulcer in Real-World Practice

2026年4月27日 更新者：Daewoong Pharmaceutical Co. LTD.

A Prospective, Multi-Center, Observational Study to Evaluate the Efficacy and Safety of Fexuclue Tablet 20 mg in Patients Requiring NSAIDs-Induced Peptic Ulcer Prevention

This study is a prospective, multi-center, observational study to evaluate the efficacy and safety of Fexuclue Tablet 20 mg in patients requiring prevention of NSAIDs-induced peptic ulcer in real-world clinical practice in Korea.

Patients receiving NSAIDs and requiring gastroprotective therapy will be enrolled and followed prospectively. The study will assess patient-reported outcomes (PROs) related to gastrointestinal symptoms, as well as safety outcomes.

研究概览

地位

尚未招聘

条件

详细说明

This study is a prospective, multi-center, observational study conducted in Korea to evaluate the efficacy and safety of Fexuclue Tablet 20 mg in patients requiring prevention of NSAIDs-induced peptic ulcer in routine clinical practice.

Adult patients receiving NSAIDs who require prevention of peptic ulcer will be enrolled after providing written informed consent. Treatment with Fexuclue Tablet will be prescribed based on the physician's clinical judgment in accordance with approved labeling.

The study will primarily evaluate patient-reported outcomes (PROs) related to gastrointestinal symptoms using electronic PRO (ePRO) questionnaires. Assessments will be conducted at baseline and at approximately 2, 4, 8, and 12 weeks after treatment initiation.

Safety will be assessed by monitoring adverse events. This study aims to provide real-world evidence on symptom prevention and improvement in patients requiring NSAIDs-induced peptic ulcer prevention.

研究类型

观察性的

注册 (估计的)

7000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 韩国
      • Seoul、韩国
        • Multiple centers in Republic of Korea
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

This study will enroll adult patients aged 19 years or older who require prevention of NSAIDs-induced peptic ulcer in routine clinical practice in Korea. Eligible patients are those who are prescribed Fexuclue Tablet 20 mg based on the physician's clinical judgment.

Patients receiving NSAIDs and requiring gastroprotective therapy will be prospectively enrolled from multiple centers under real-world conditions. Treatment decisions will be made according to routine clinical practice.

Patients with contraindications to the study drug or those deemed inappropriate by the investigator will be excluded.

描述

Inclusion Criteria:

  • Adults aged ≥19 years
  • Patients requiring NSAIDs therapy
  • Patients requiring prevention of NSAIDs-induced peptic ulcer
  • Patients prescribed Fexuclue Tablet 20 mg
  • Patients who provide written informed consent

Exclusion Criteria:

  • Hypersensitivity to Fexuclue or its components
  • Severe hepatic impairment
  • Pregnant or breastfeeding women
  • Patients considered inappropriate by investigator

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Fexuclue Treatment Group
Patients requiring prevention of NSAIDs-induced peptic ulcer who are prescribed Fexuclue Tablet 20 mg in routine clinical practice.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 2
大体时间：Week 2

Peptic ulcer symptoms will be assessed using a study-specific patient-reported outcome (PRO) questionnaire consisting of 6 symptom items.

Each symptom is scored on a scale from 0 (none) to 4 (very severe).

Symptom occurrence is defined as:

Increase of ≥1 point in at least one symptom item compared to baseline

Includes:

New occurrence in asymptomatic patients Worsening in symptomatic patients

The proportion (%) of patients with symptom occurrence at Week 2 will be calculated.
Week 2

次要结果测量

结果测量
措施说明
大体时间
Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 4
大体时间：Week 4

Peptic ulcer symptom occurrence is defined using the same criteria as the primary endpoint (≥1-point increase in at least one symptom item from baseline).

The proportion (%) of patients with symptom occurrence will be calculated at Week 4
Week 4
Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 8
大体时间：Week 8

Peptic ulcer symptom occurrence is defined using the same criteria as the primary endpoint (≥1-point increase in at least one symptom item from baseline).

The proportion (%) of patients with symptom occurrence will be calculated at Week 8
Week 8
Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 12
大体时间：Week 12

Peptic ulcer symptom occurrence is defined using the same criteria as the primary endpoint (≥1-point increase in at least one symptom item from baseline).

The proportion (%) of patients with symptom occurrence will be calculated at Week 12
Week 12
Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 2
大体时间：Week 2

Gastrointestinal symptoms will be assessed using a study-specific PRO questionnaire with 6 symptom items, each scored from 0 (none) to 4 (very severe).

The total score ranges from 0 to 24, with higher scores indicating more severe symptoms.

The outcome measure is defined as the change from baseline in total score at each time point.
Week 2
Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 4
大体时间：Week 4

Gastrointestinal symptoms will be assessed using a study-specific PRO questionnaire with 6 symptom items, each scored from 0 (none) to 4 (very severe).

The total score ranges from 0 to 24, with higher scores indicating more severe symptoms.

The outcome measure is defined as the change from baseline in total score at each time point.
Week 4
Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 8
大体时间：Week 8

Gastrointestinal symptoms will be assessed using a study-specific PRO questionnaire with 6 symptom items, each scored from 0 (none) to 4 (very severe).

The total score ranges from 0 to 24, with higher scores indicating more severe symptoms.

The outcome measure is defined as the change from baseline in total score at each time point.
Week 8
Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 12
大体时间：Week 12

Gastrointestinal symptoms will be assessed using a study-specific PRO questionnaire with 6 symptom items, each scored from 0 (none) to 4 (very severe).

The total score ranges from 0 to 24, with higher scores indicating more severe symptoms.

The outcome measure is defined as the change from baseline in total score at each time point.
Week 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Daewoong Pharmaceutical Co. LTD.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年4月30日

初级完成 (估计的)

2027年4月30日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2026年3月31日

首先提交符合 QC 标准的

2026年4月27日

首次发布 (实际的)

2026年4月30日

研究记录更新

最后更新发布 (实际的)

2026年4月30日

上次提交的符合 QC 标准的更新

2026年4月27日

最后验证

2026年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • DW_FEX_DB_04

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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