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The purpose of this study was to evaluate the efficacy and safety of tegoprazan and minocycline dual therapy for Helicobacter pylori initial treatment. It is hypothesized that tegoprazan and minocycline dual therapy is non-inferior to bismuth-containing quadruple therapy.Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tegoprazan and minocycline dual theropy | Experimental | tegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days |
|
| Bismuth-containing quadruple therapy | Active Comparator | bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tegoprazan | Drug | tegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter pylori eradication rate | The primary end point of this study is H.pylori eradication,established by negative urea breath test#rapid urease test or helicobacter pylori stool antigen test 28 days after the end of treament | 28 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (Safety) | Newly occurring drug-related symptoms during the treatment process | 14 days of treatment |
| Rate of participants with good medication compliance (Compliance) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yongquan Shi, | Chinaa, Shaanxi Xijing Hosipital of Digestive Disease | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing hospital | Xi'an | Shaanxi | 710032 | China |
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| Minocycline | Drug | tegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days |
|
| bismuth potassium citrate | Drug | bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days |
|
| Esomeprazole 40mg | Drug | bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days |
|
| Amoxicillin | Drug | bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days |
|
| clarithromycin | Drug | bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days |
|
Taking more than 80% of medication is defined as good compliance
| 14 days of treatment |
| ID | Term |
|---|---|
| C000631239 | tegoprazan |
| D008911 | Minocycline |
| D064098 | Esomeprazole |
| D000658 | Amoxicillin |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
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