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This study is a single center, randomized controlled clinical study. The enrolled patients are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea breath test. According to the declaration of Helsinki, 327 patients will be included in this study. After obtaining the written informed consent of the patients, HP culture and drug sensitivity test will be conducted on all the selected patients with the success rate, adverse reactions, compliance, antibiotic resistance of HP and its impact on HP eradication.
According to relevant literature research, amoxicillin TID groups (including before meal group and after meal group) were given Vonorasen (Takeda China) 20mg bid and Amoxicillin 1.0 TID (Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd.). Amoxicillin Qid group was given Vonorasen (Takeda China) 20mg bid and Amoxicillin 0.75 Qid (Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd.), all the drugs were purchased by the patients from the hospital. The three groups were treated for 14 days respectively, and 13C urea breath test was performed 6 weeks after drug withdrawal. The negative ones were judged as HP eradication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dual therapy A | Experimental | Vonoprazan 20mg bid ac and amoxicillin 0.75g qid pc |
|
| dual therapy B | Experimental | Vonoprazan 20mg bid ac and amoxicillin 1g tid pc |
|
| dual therapy C | Experimental | Vonoprazan 20mg bid ac and amoxicillin 1g tid ac |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vonoprazan | Drug | Potassium competitive acid blocker |
|
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter pylori eradication rate | Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-rea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value). | Six weeks after completion of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adverse events | The subjects were asked to record side effects and discomfort during treatment and actual drug administration. | Within 7 days after completion of therapy |
| Compliance rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | 200127 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39087868 | Derived | Qiu S, Huang Y, Chen J, Guo Y, Li M, Ding Z, Liang X, Lu H. Vonoprazan-Amoxicillin Dual Therapy With Different Amoxicillin Administration Regimens for Helicobacter pylori Treatment: A Randomized Controlled Trial. Helicobacter. 2024 Jul-Aug;29(4):e13118. doi: 10.1111/hel.13118. |
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| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Amoxicillin | Drug | Antibiotics for H. pylori eradication |
|
Compliance was defined as poor when they had taken less than 80% of the total medication
| Within 7 days after completion of therapy |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |