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This is a multicenter, randomized, double blind, double-simulated, parallel control of positive drug phase III clinical study to evaluate the efficacy and safety of Anaprazole versus Esomeprazole-containing Bismuth quadruple therapy for eradication of Helicobacter pylori in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anaprazole sodium enteric-coated tablets | Experimental | Anaprazole sodium enteric-coated tablets + Esomeprazole magnesium enteric-coated tablets placebo +Bismuth potassium citrate capsules + Amoxicillin capsules + Clarithromycin tablets |
|
| Esomeprazole magnesium enteric-coated tablets | Active Comparator | Anaprazole sodium enteric-coated tablets placebo + Esomeprazole magnesium enteric-coated tablets +Bismuth potassium citrate capsules + Amoxicillin capsules + Clarithromycin tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anaprazole Sodium enteric-coated tablet | Drug | Anaprazole sodium enteric-coated tablets 20mg + Esomeprazole magnesium enteric-coated tablets placebo 1 tablet +Bismuth potassium citrate capsules 240mg + Amoxicillin capsules 1000mg + Clarithromycin tablets 500mg,BID,oral,twice daily for 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of all participants with successful Helicobacter Pylori (Hp) eradication | Percentage of all patients with Hp eradication determined by a 13^C-urea breath test after study treatment | Day 28+7 days following the completion of treatment(duration of treatment was 2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with successful Helicobacter Pylori (H.Pylori) eradication in participants with Clarithromycin-resistant strain and Clarithromycin-sensitive strain of H.Pylori at baseline | Day 28+7 days following the completion of treatment(duration of treatment was 2 weeks) | |
| Percentage of participants with successful Helicobacter Pylori (H.Pylori) eradication in participants with Amoxicillin-resistant strain and Amoxicillin-sensitive strain of H.Pylori at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events (AEs) | Day 15+3 days following the completion of treatment(duration of treatment was 2 weeks) | |
| AUC0-t | Up to 14 days from the start of administration | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yaping Luo | Contact | +86-15367827140 | luoyaping@xuanzhubio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Hospital of Southern Medical University | Shenzhen | Guangdong | 518100 | China |
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|
| Esomeprazole magnesium enteric-coated tablets | Drug | Anaprazole sodium enteric-coated tablets placebo 1 tablet + Esomeprazole magnesium enteric-coated tablets20mg +Bismuth potassium citrate capsules 240mg + Amoxicillin capsules 1000mg + Clarithromycin tablets 500mg,BID,oral,twice daily for 14 days |
|
| Day 28+7 days following the completion of treatment(duration of treatment was 2 weeks) |
| AUC0-∞ |
| Up to 14 days from the start of administration |
| Cmax | Up to 14 days from the start of administration |
| Tmax | Up to 14 days from the start of administration |
| t½ | Up to 14 days from the start of administration |
| CL/F | Up to 14 days from the start of administration |
| Vz/F | Up to 14 days from the start of administration |