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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.

調査の概要

状態

まだ募集していません

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

7000

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 韓国
      • Seoul、韓国
        • Multiple centers in Republic of Korea
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
Fexuclue Treatment Group
Patients requiring prevention of NSAIDs-induced peptic ulcer who are prescribed Fexuclue Tablet 20 mg in routine clinical practice.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 2
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 4
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Daewoong Pharmaceutical Co. LTD.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年4月30日

一次修了 (推定)

2027年4月30日

研究の完了 (推定)

2027年12月31日

試験登録日

最初に提出

2026年3月31日

QC基準を満たした最初の提出物

2026年4月27日

最初の投稿 (実際)

2026年4月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年4月30日

QC基準を満たした最後の更新が送信されました

2026年4月27日

最終確認日

2026年3月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • DW_FEX_DB_04

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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