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| Name | Class |
|---|---|
| Linyi People's Hospital | OTHER |
| Weifang Medical University | OTHER |
| Zhengzhou Central Hospital | OTHER |
| Yuncheng Traditional Chinese Medicine Hospital |
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Helicobacter pylori (H. pylori) infection is a common global infectious disease of the gastrointestinal tract. Helicobacter pylori eradication can effectively prevent the development of stomach cancer. Progressive application of dual therapy for the eradication of Helicobacter pylori. Tegoprazan, a Potassium-Competitive Acid Blockers. The efficacy of P-CAB agents represented by vonoprazan in H. pylori eradication therapy has been widely verified.
In 1989, it was suggested that amoxicillin combined with PPI could eradicate Hp infection, and in 2015, a prospective, multicenter, randomized controlled study in Taiwan with a large sample showed that the eradication rate of Hp could reach 96.6% with dual therapy for primary treatment of Hp infection, and the results of intention-to-treat analysis were as high as 95.3%. 95.3%. In 2020, a meta-analysis showed that high-dose dual therapy had the same efficacy and fewer side effects than other recommended regimens in first-line treatment. In terms of dosing days, multiple randomized controlled studies and meta-analyses from 2020-2021 have shown that 14 days of high-dose dual therapy is more effective in eradicating H. pylori.
Tegoprazan, a Potassium-Competitive Acid Blockers (P-CAB), is a new type of acid-suppressing drug that compensates for the short half-life of acid-activated traditional acid-suppressing PPI and the low mucosal healing rate due to insufficient acid suppression. The efficacy of P-CAB agents represented by vonoprazan in H. pylori eradication therapy has been widely verified. 2022, tegoprazan was approved by the State Drug Administration for the new indication of eradication of H. pylori infection in adults in combination with appropriate antimicrobial therapy, and its efficacy in clinical application has not yet been verified.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14-day Tegoprazan-Amoxicillin dual therapy | Experimental | 14-day Tegoprazan-Amoxicillin dual therapy, Tegoprazan(Luo Xin Pharmaceutical Group Co. LTD)50mg bid, Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid |
|
| 14-day Esomeprazole-Amoxicillin dual therapy | Active Comparator | 14-day Esomeprazole-Amoxicillin dual therapy, Esomeprazole(Astrazeneca Pharmaceutical Co., LTD.) 20mg qid, Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegoprazan | Drug | Included in dual eradication medication. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate | Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 80% of the study medications and complete follow-up. | Immediately after follow-up check |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adverse reactions | Rate of adverse reactions | Immediately after follow-up check |
| Patient compliance | good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanqing Li, MD | Contact | 18560086667 | qlxhkqz@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanqing Li | Qilu Hospital of Shandong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Qilu Hospital, Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27707777 | Result | Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5. | |
| 38853394 |
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| ID | Term |
|---|---|
| C000631239 | tegoprazan |
| D000658 | Amoxicillin |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
| The People's Hospital of Jimo | UNKNOWN |
| Shandong University of Traditional Chinese Medicine | OTHER |
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| Amoxicillin |
| Drug |
Included in dual eradication medication. |
|
| Esomeprazole | Drug | Included in dual eradication medication. |
|
| Immediately after follow-up check |
| Derived |
| Kong Q, Mirza IA, Zhang X, Song X, Li X, Zhang Q, Xu L, Guo Y, Yu Y, Zuo X, Li Y, Li Y. Fourteen-Day Tegoprazan-Amoxicillin Dual Therapy as the First-Line Treatment of Helicobacter pylori Infection (SHARE2301): A Multicenter, Noninferiority, Randomized Clinical Trial. Helicobacter. 2024 May-Jun;29(3):e13098. doi: 10.1111/hel.13098. |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |