A RCT of the Efficacy of Tegoprazan 50mg QD in the Treatment of Helicobacter Pylori Infection ( TATH-1 )

Study Overview
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Brief Summary
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The treatment of helicobacter pylori is very important. The routine treatment is quadruple therapy. In recent years, double therapy has appeared and the curative effect is fair. However, antacid generally uses proton pump inhibitor. The proton pump inhibitor needs double dose to achieve good antacid curative effect. The effect of Tegoprazan used for inhibiting gastric acid is better than proton pump inhibitor. At present, some studies use Tegoprazan instead of common proton pump inhibitor, but almost all use double dose of Tegoprazan. In the previous study, we found that the effect of double dose of proton pump inhibitor can be achieved with 50mg QD of Tegoprazan. Therefore, in this study, 50mg QD of Tegoprazan was used to replace the double dose of proton pump inhibitor to observe the antibacterial effect of Tegoprazan on Helicobacter pylori.

Detailed Description
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The treatment of helicobacter pylori is very important. The routine treatment is quadruple therapy. In recent years, double therapy has appeared and the curative effect is fair. However, antacid generally uses proton pump inhibitor. The proton pump inhibitor needs double dose to achieve good antacid curative effect. The effect of Tegoprazan used for inhibiting gastric acid is better than proton pump inhibitor. At present, some studies use Tegoprazan instead of common proton pump inhibitor, but almost all use double dose of Tegoprazan. In the previous study, we found that the effect of double dose of proton pump inhibitor can be achieved with 50mg QD of Tegoprazan. Therefore, in this study, 50mg QD of Tegoprazan was used to replace the double dose of proton pump inhibitor to observe the antibacterial effect of Tegoprazan on Helicobacter pylori.

Official Title
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A RCT of the Efficacy of Tegoprazan 50mg QD Combined With Amoxicillin 750mg QID in the Treatment of Helicobacter Pylori Infection

Conditions
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Vonoprazan, Helicobacter Pylori Infection, Proton Pump Inhibitor

Intervention / Treatment
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* Drug: Tegoprazan
* Drug: Esomeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged ≥18 years with Hp-positive first sterilization were included in this study. Before treatment, the existence of Helicobacter pylori can be confirmed by one or more of the following methods: rapid urease test, Hp culture, 13C urea breath test, 14C urea breath test and stool Hp antigen test. Exclusion Criteria: acute upper gastrointestinal bleeding. active gastric or duodenal ulcer. acute gastric or duodenal mucosal lesions. previous eradication treatment of Helicobacter pylori. penicillin/furazolidone allergy. surgery that may affect gastric acid secretion (upper gastrointestinal resection or vagotomy). Zollinger-Ellison syndrome or other hypergastric acid secretion diseases. severe neurological, cardiovascular, pulmonary, liver,renal, metabolic,gastrointestinal, urological, etc. Any fertile woman must use proper contraception.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tegoprazan 50mg QD<br>Tegoprazan 50mg, tablets, orally, qd given in combination with amoxicillin 750mg capsules, orally, qid for up to 2 weeks | Drug: Tegoprazan<br>* Tegoprazan 50 mg, tablets, orally, qd given in combination with amoxicillin 750mg capsules, orally, qid for up to 2 weeks.<br>|
| Active Comparator: Esomeprazole 20 mg BID<br>esomeprazole 20 mg, tablets, orally, bid given in combination with amoxicillin 1000mg，clarithromycin 500mg bid，colloidal bismuth pectin 200mg bid for up to 2 weeks. OR esomeprazole 20 mg, tablets, orally, bis in die given in combination with amoxicillin 750mg capsules, orally, quarter die for up to 2 weeks. | Drug: Esomeprazole<br>* esomeprazole 20 mg, tablets, orally, bid given in combination with amoxicillin 1000mg，clarithromycin 500mg bid，colloidal bismuth pectin 200mg bid for up to 2 weeks. OR esomeprazole 20 mg, tablets, orally, bis in die given in combination with amoxicillin 750mg capsules, orally, quarter die for up to 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post- Treatment | HP infection status will be determined by ^13C Urea Breath Test (^13C-UBT). The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory. | Week 4 post-treatment |