Clinical trial
Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication:A Prospective, Multicenter, Open-label Randomized Controlled Study
Name
KY20240123-18
Description
It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with Vonoprazan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.
Trial arms
Trial start
2024-05-01
Estimated PCD
2024-10-31
Trial end
2024-12-31
Status
Not yet recruiting
Treatment
Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days
Group A:The patient was treated with oral Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid + doxycycline 0.1 g, bid + bismuth for 14 days.
Arms:
Group A Bismuth quadruple
Other names:
Doxycycline-based Bismuth Quadruple Therapy
Vonoprazan+Amoxicillin
Group B: Patients were treated with oral Vonoprazan 20mg, bid + amoxicillin 1.0g, bid for 14 days.
Arms:
Group B Amoxicillin Dual therapy
Other names:
Vonoprazan+Amoxicillin Dual therapy
Vonoprazan+doxycycline
Group C: Patients were treated with oral Vonoprazan 20 mg, bid + doxycycline 0.1 g, bid for 14 days.
Arms:
Group C doxycycline Dual therapy
Other names:
Vonoprazan+doxycycline Dual therapy
Size
810
Primary endpoint
HP eradication rate
4-6 weeks after the end of the last dose
Eligibility criteria
Inclusion Criteria:
1. Age 18-65 years old;
2. Patients confirmed to be positive for H. pylori by 13C-UBT or 14C-UBT;
3. Patients who have not received Helicobacter pylori eradication therapy before, or patients who have failed to eradicate in the early stage but have not received eradication therapy within half a year;
4. Voluntarily join this trial and sign the informed consent form.
Exclusion Criteria:
1. Allergy to the study drug (penicillin, amoxicillin, Vonoprazan, doxycycline, etc.);
2. Patients with confirmed active peptic ulcer;
3. Patients who have received Helicobacter pylori eradication therapy within half a year;
4. Use of antibiotics, bismuth, and histamine H2 receptor antagonists or PPIs for the first 2 weeks before starting study treatment;
5. Use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs, anticoagulants, barbiturates, phenytoin, or carbamazepine drugs;
6. History of esophageal or gastric surgery;
7. Pregnant or lactating women;
8. Alcoholism
9. Suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;
10. Hepatic insufficiency caused by hepatitis, fatty liver and other reasons;
11. Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant tumor diseases.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 810, 'type': 'ESTIMATED'}}
Updated at
2024-05-14
1 organization
3 products
1 indication
Organization
Nanjing First HospitalIndication
Helicobacter pylori infectionProduct
Vonoprazan+AmoxicillinProduct
Vonoprazan+doxycycline