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As H. pylori eradication, the investigators prepared a randomized controlled clinical trial whether tegoprazan-containing 10-day sequential treatment was effective compared to conventional PPI-containing 10-day sequential eradication therapy
Eradication treatment containing potassium-competitive acid blocker has shown acceptable eradication efficacy. In regions such as Korea, where the prevalence of antimicrobial resistance is high, alternative combinations of antibiotics such as sequential or concomitant therapy are needed. This study compared the outcome of sequential therapy containing tegoprazan, a new potassium-competitive acid blocker, with the conventional esomeprazole-containing sequential therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esomeprazole-containing sequential H. pylori eradication therapy (conventional method) | Active Comparator | esomeprazole (40 mg) plus amoxicillin (1000 mg) twice a day for initial 5 days, and then esomeprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for the remaining 5 days. |
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| Tegoprazan-containing sequential H. pylori eradication therapy (experimental method) | Experimental | tegoprazan (50 mg) plus amoxicillin (1000 mg) twice a day for initial 5 days, and then tegoprazan (50 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for the remaining 5 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegoprazan-containing sequential H. pylori eradication therapy | Drug | tegoprazan was administered, instead propton-pump inhibitor, as acid blockade in H. pylori eradication sequential therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate | Efficacy of H. pylori eradication therapy. confirmed by negative UBT test | 2 or 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | any adverse events occured during or after intervention (eradication therapy) | up to 6 month |
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Inclusion Criteria:
Patients who had H. pylori infection proved by positive test result of urea breath test (UBT), rapid urase test or pathologic examination (warthin-giemsa staining)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jungwon Lee, Dr. | Contact | 821093567758 | saludos@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Nayoung Kim, Prof. | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39434634 | Derived | Lee JW, Kim N, Lee J, Jo SY, Lee DH. Efficacy of Tegoprazan-Containing Sequential Eradication Treatment Compared to Esomeprazole-Containing Sequential Eradication of Helicobacter pylori in South Korea, a Region With High Antimicrobial Resistance: A Prospective, Randomized, Single Tertiary Center Study. Helicobacter. 2024 Sep-Oct;29(5):e13143. doi: 10.1111/hel.13143. |
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| Esomeprazole-containing sequential H. pylori eradication therapy | Drug | Esomeprazole was administered as acid blockade in H. pylori eradication sequential therapy (conventional acid blockade method for sequential eradication therapy) |
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