Patients on Treatment With Systemic SteroidsPhase 4NCT05946135
Efficacy of Fexuprazan for Prevention or Control of Gastritis Symptoms in Patients on Treatment With Systemic Steroids
A Phase 4 study testing Lansoprazole and Fexuprazan Hydrochloride in people with Patients on Treatment With Systemic Steroids, run by Yonsei University at 1 site in South Korea.
Trial summary
This clinical trial is conducted as a double-blind, randomized, and active drug control clinical trial. If the screening results determine that the selection/exclusion criteria are met, the clinical trial drugs are randomly assigned at a 1:1 ratio of the Pexuprazan 40 mg and the Lansoprazole 15 mg dose group and taken… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Patients on Treatment With Systemic Steroids
- What is being tested?
- Lansoprazole and Fexuprazan Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Nov 2023to 8 Sep 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A person who voluntarily signed a consent form
- Adult men and women over 20 years of age
- Patients who require systemic steroid treatment of at least 4 weeks of moderate dose (20 mg/day or more based on prednisolone) due to respiratory diseases during screening
- Patients who are already on steroids can also participate (If there is a gastric protective agent in use, patients should agree to replace it with clinical trial drug)
- Patients who satisfy both of the following in relation to the evaluation index of gastritis symptoms during screening
- Gastritis symptom frequency indicator: 5 points or less
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- Gastritis symptom intensity indicator: 5 points or less
- A person who has at least one of the following risk factors for gastric ulcer during screening
- ① Long-term use of NSAIDs for longer than 12 weeks (NSAIDs should be maintained continuously during the clinical trial.)
- ② A person who has a history of peptic ulcer in the past
- ③ 50 years of age or older
- ④ In combination with low-dose aspirin (aspirin 325 mg/day or less) (Low-dose aspirin should be maintained continuously during the clinical trial.)
- A person who understand and follow the guidance of the research manager according to the research plan, and who can participate whole period of clinical trial
Who cannot join
- A person who has a hypersensitivity reaction to the components of this clinical trial drug or benzimidazole-based drug or has a history of clinically significant hypersensitivity reaction
- A person who has undergone surgery that may affect gastric acid secretion, such as upper gastrointestinal resection, gastric acid secretion inhibition surgery, and gastric mucosal resection
- Those who have a history of gastrointestinal malignancies within 5 years of screening (excluding after endoscopic resection of gastric carcinoma or early gastric cancer)
- Patients with Barrett's esophagus (over 3 cm), gastroesophageal varices, esophageal stenosis, ulcer stenosis, active peptic ulcers, and acute gastrointestinal bleeding
- Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis, etc.), irritable bowel syndrome (IBS), primary esophageal motility disorder, and pancreatitis
- Patients with eosinophilic esophagitis (if the esophageal biopsy determines that it is not eosinophilic esophagitis, they can participate)
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- Those who have a history of gastric acid secretion disorders such as Zolinger-Elison syndrome
- A person who is currently confirmed positive for Helicobacter pyrroly infection
- Persons taking medications contraindicated to clinical trial drug (e.g., atazanavir, nelfinavir, or rilpivirine-containing agents)
- Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption disorder
- Patients with severe renal and liver disorders according to the physician's judgment
- A person who disagrees with the appropriate use of contraception by himself/herself or his/her partner during the clinical trial period
- Pregnant women or breast feeding women
- Any person who has any clinical findings that are deemed medically inappropriate for this trial under the judgment of the research manager
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Active Controlled Clinical Trial to Evaluate the Efficacy of Fexuprazan for the Prevention or Control of Gastritis Symptoms in Patients on Treatment With Systemic Steroids (FEAST)
- This clinical trial is conducted as a double-blind, randomized, and active drug control clinical trial. If the screening results determine that the selection/exclusion criteria are met, the clinical trial drugs are randomly assigned at a 1:1 ratio of the Pexuprazan 40 mg and the Lansoprazole 15 mg dose group and taken for 4 weeks.
- Gastritis symptoms are evaluated four weeks after baseline (Visit1) and clinical drug administration (Visit2), and if it is determined that gastritis is necessary according to the medical team's judgment due to gastrointestinal symptoms during the study participation period, endoscopy is performed to check whether gastritis occurs.
- Being tested
- Lansoprazole, Fexuprazan Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LansoprazoleDrug
taking lansoprazole + placebo for Fexuprazan Hydrochloride for 4 weeks
Fexuprazan HydrochlorideDrug
taking placebo for lansoprazole + Fexuprazan Hydrochloride for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | lansoprazole + placebo for Fexuprazan Hydrochloride Receives: Drug: Lansoprazole |
| Intervention | Experimental | placebo for lansoprazole + Fexuprazan Hydrochloride Receives: Drug: Fexuprazan Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in baseline gastritis symptoms based on gastritis symptom index at 4 weeks
To evaluate the effect of preventing gastritis symptoms, changes in gastritis symptoms using gastritis symptom index after 4 weeks compared to baseline were compared. The gastritic symptoms index consisted of 10 items to be questioned about the frequency and degree of symptoms over the past 4 weeks.
Measured: baseline and 4 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start7 Nov 2023
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients on Treatment With Systemic SteroidsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ji Ye Jung, Principal investigator, Severance Hospital, Division of Pulmonary and Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946135
- Sponsor's protocol ID
- 4-2023-0598
- Status last verified
- Jan 2026
- First submitted
- 6 Jul 2023
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active Controlled Clinical Trial to Evaluate the Efficacy of Fexuprazan for the Prevention or Control of Gastritis Symptoms in Patients on Treatment With Systemic Steroids (FEAST)
- ClinicalTrials.gov ID
- NCT05946135
- Acronym / sponsor ID
- 4-2023-0598
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 14 Jul 2023 (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 clinical trial is conducted as a double-blind, randomized, and active drug control clinical trial. If the screening results determine that the selection/exclusion criteria are met, the clinical trial drugs are randomly assigned at a 1:1 ratio of the Pexuprazan 40 mg and the Lansoprazole 15 mg dose group and taken for 4 weeks.
- Gastritis symptoms are evaluated four weeks after baseline (Visit1) and clinical drug administration (Visit2), and if it is determined that gastritis is necessary according to the medical team's judgment due to gastrointestinal symptoms during the study participation period, endoscopy is performed to check whether gastritis occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Lansoprazolelansoprazole + placebo for Fexuprazan Hydrochloride |
| Intervention | Experimental | Drug: Fexuprazan Hydrochlorideplacebo for lansoprazole + Fexuprazan Hydrochloride |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- A person who voluntarily signed a consent form
- Adult men and women over 20 years of age
- Patients who require systemic steroid treatment of at least 4 weeks of moderate dose (20 mg/day or more based on prednisolone) due to respiratory diseases during screening
- Patients who satisfy both of the following in relation to the evaluation index of gastritis symptoms during screening
- A person who has at least one of the following risk factors for gastric ulcer during screening
Key exclusion criteria (14 listed)
- A person who has a hypersensitivity reaction to the components of this clinical trial drug or benzimidazole-based drug or has a history of clinically significant hypersensitivity reaction
- A person who has undergone surgery that may affect gastric acid secretion, such as upper gastrointestinal resection, gastric acid secretion inhibition surgery, and gastric mucosal resection
- Those who have a history of gastrointestinal malignancies within 5 years of screening (excluding after endoscopic resection of gastric carcinoma or early gastric cancer)
- Patients with Barrett's esophagus (over 3 cm), gastroesophageal varices, esophageal stenosis, ulcer stenosis, active peptic ulcers, and acute gastrointestinal bleeding
- Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis, etc.), irritable bowel syndrome (IBS), primary esophageal motility disorder, and pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lansoprazoletaking lansoprazole + placebo for Fexuprazan Hydrochloride for 4 weeks | Drug | Control |
| Fexuprazan Hydrochloridetaking placebo for lansoprazole + Fexuprazan Hydrochloride for 4 weeks | Drug | Intervention |
Primary outcome
Changes in baseline gastritis symptoms based on gastritis symptom index at 4 weeks
Time frame: baseline and 4 weeks later
To evaluate the effect of preventing gastritis symptoms, changes in gastritis symptoms using gastritis symptom index after 4 weeks compared to baseline were compared. The gastritic symptoms index consisted of 10 items to be questioned about the frequency and degree of symptoms over the past 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Ji Ye Jung principal investigator
Severance Hospital, Division of Pulmonary and Critical Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lansoprazole and Fexuprazan Hydrochloride in people with Patients on Treatment With Systemic Steroids, run by Yonsei University 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 13 inclusion and 14 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: finished, as of the sponsor's last update on 13 Jan 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in baseline gastritis symptoms based on gastritis symptom index at 4 weeks (time frame: baseline and 4 weeks later). 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 13 Jan 2026.