Peptic UlcerNCT07558707
Fexuclue for Prevention of NSAIDs-Induced Peptic Ulcer in Real-World Practice
An observational study of Peptic Ulcer and NSAID-Induced Peptic Ulcer, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Peptic Ulcer, NSAID-Induced Peptic Ulcer
- Type of treatment
- Pill or oral medicine
- How many people
- 7,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Apr 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Hypersensitivity to Fexuclue or its components
- Severe hepatic impairment
- Pregnant or breastfeeding women
- Patients considered inappropriate by investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Multiple centers in Republic of Korea
Seoul
SoHeui Kim, 82-10-2994-5887, 2210325@daewoong.co.kr
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Peptic Ulcer, NSAID-Induced Peptic Ulcer
- Keywords
- NSAIDs, Fexuprazan, PRO, Real-World, Peptic Ulcer Prevention
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fexuclue Treatment Group | Patients requiring prevention of NSAIDs-induced peptic ulcer who are prescribed Fexuclue Tablet 20 mg in routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 2
Secondary outcomes (7)
Proportion of Patients with Peptic Ulcer Symptom Occurrence at 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
Measured: Week 4
Proportion of Patients with Peptic Ulcer Symptom Occurrence at 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
Measured: Week 8
Proportion of Patients with Peptic Ulcer Symptom Occurrence at 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
Measured: Week 12
Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at 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.
Measured: Week 2
Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at 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.
Measured: Week 4
Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at 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.
Measured: Week 8
Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at 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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic UlcerStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558707
- Sponsor's protocol ID
- DW_FEX_DB_04
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07558707
- Acronym / sponsor ID
- DW_FEX_DB_04
- Conditions
- Peptic Ulcer, NSAID-Induced Peptic Ulcer
- Keywords
- NSAIDs, Fexuprazan, PRO, Real-World, Peptic Ulcer Prevention
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fexuclue Treatment Group | – | –Patients requiring prevention of NSAIDs-induced peptic ulcer who are prescribed Fexuclue Tablet 20 mg in routine clinical practice. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Hypersensitivity to Fexuclue or its components
- Severe hepatic impairment
- Pregnant or breastfeeding women
- Patients considered inappropriate by investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 2
Time frame: 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.
7 secondary outcomes
Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 4
Time frame: Week 4
Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 8
Time frame: Week 8
Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 12
Time frame: Week 12
Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 2
Time frame: Week 2
Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 4
Time frame: Week 4
Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 8
Time frame: Week 8
Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 12
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peptic Ulcer and NSAID-Induced Peptic Ulcer, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SoHeui Kim (82-10-2994-5887, 2210325@daewoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 2 (time frame: Week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.