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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | lansoprazole + placebo for Fexuprazan Hydrochloride |
|
| Intervention | Experimental | placebo for lansoprazole + Fexuprazan Hydrochloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole | Drug | taking lansoprazole + placebo for Fexuprazan Hydrochloride for 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 4 weeks later |
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Inclusion Criteria:
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
- Gastritis symptom frequency indicator: 5 points or less
- 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
â‘ Long-term use of NSAIDs for longer than 12 weeks (NSAIDs should be maintained continuously during the clinical trial.)
â‘¡ A person who has a history of peptic ulcer in the past
â‘¢ 50 years of age or older
â‘£ 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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ji Ye Jung | Severance Hospital, Division of Pulmonary and Critical Care Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Fexuprazan Hydrochloride |
| Drug |
taking placebo for lansoprazole + Fexuprazan Hydrochloride for 4 weeks |
|
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |