Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to evaluate the efficacy of vonoprazan combined with different antibiotics in dual therapy for Helicobacter pylori eradication treatment. Newly infected patients were randomly assigned to four groups: amoxicillin dual therapy, tetracycline dual therapy, minocycline dual therapy, and bismuth quadruple therapy. At the follow - up visit in the 6th week, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be conducted to confirm eradication.
The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.
Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 14 and 16.
Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test#rapid urease test or helicobacter pylori stool antigen test.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vonoprazan - amoxicillin dual therapy | Experimental | Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days |
|
| Vonoprazan-tetracycline dual therapy | Experimental | Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days |
|
| Vonoprazan-minocycline dual therapy | Experimental | Vonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days |
|
| Bismuth-containing quadruple therapy | Active Comparator | Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan | Drug | Vonoprazan - amoxicillin dual therapy: Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days; Vonoprazan-tetracycline dual therapy:Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days; Vonoprazan-minocycline dual therapy:Vonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days; Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter pylori eradication | The primary end point of this study is H.pylori eradication#established by negative [13C] urea breath test #DOB value below 3.9#28 days after the end of eradication | 28 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache,dizziness,skin rash,other gastrointestinal disorders,pyrexia,cough and back pain | 14 days of treatment, and 28 days after treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongquan Shi, Ph. D | Contact | 86-29-84771515 | shiyquan@fmmu.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hosipital of Digestive Disease | Recruiting | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42141850 | Derived | Li J, Li DH, Guo QQ, Zhang J, Zhu XJ, Liu YH, Zhang YP, Chen M, Shi YQ. Efficacy and Safety of Vonoprazan-Based Dual Therapies With Different Antibiotics Versus Bismuth-Containing Quadruple Therapy for Helicobacter pylori Eradication: A Prospective, Four-Arm, Randomized Controlled Trial. Helicobacter. 2026 May-Jun;31(3):e70132. doi: 10.1111/hel.70132. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Tetracycline 500mg tid | Drug | Vonoprazan-tetracycline dual therapy:Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days |
|
| Minocycline | Drug | Vonoprazan-minocycline dual therapy Vonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days |
|
| Bismuth | Drug | Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days |
|
| Clarithromycin 500 mg | Drug | Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days |
|
| Amoxicillin | Drug | Vonoprazan - amoxicillin dual therapy:Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days; Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days |
|
| ID | Term |
|---|---|
| D005756 | Gastritis |
| D004415 | Dyspepsia |
| D013274 | Stomach Neoplasms |
| D010437 | Peptic Ulcer |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D013752 | Tetracycline |
| D008911 | Minocycline |
| D001729 | Bismuth |
| D017291 | Clarithromycin |
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D004603 | Elements, Radioactive |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019216 | Metals, Heavy |
| D011868 | Radioisotopes |
| D007554 | Isotopes |
| D008670 | Metals |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided