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

NCT07558707 | Not Yet Recruiting

• 1 other identifier: DW_FEX_DB_04
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peptic Ulcer; NSAID-Induced Peptic Ulcer

Keywords

NSAIDs; Fexuprazan; PRO; Real-World; Peptic Ulcer Prevention

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients with Peptic Ulcer Symptom Occurrence at 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

Secondary Outcomes (7)

• Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 4

  Week 4

• Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 8

  Week 8

• Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 12

  Week 12

• Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 2

  Week 2

• Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 4

  Week 4

Study Arms (1)

Fexuclue Treatment Group

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Multiple centers in Republic of Korea

Seoul, South Korea

Location

MeSH Terms

Conditions

Peptic Ulcer

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Central Study Contacts

SoHeui Kim

CONTACT

82-10-2994-5887; 2210325@daewoong.co.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 30, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-03

Locations

KR (1)