Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication

Phase 4

Recruiting

• Conditions: the Eradication Rates of Helicobacter Pylori
• Interventions: Drug: Vonoprazan+amoxicillin+tetracycline 14 days; Drug: Vonoprazan+amoxicillin+clarithromycin 14 days; Drug: Vonoprazan+amoxicillin+clarithromycin 7 days; Drug: Vonoprazan+tetracycline+furazolidone 7 days; Drug: Vonoprazan+amoxicillin+furazolidone 7 days; Drug: Vonoprazan+amoxicillin 14 days; Drug: Rabeprazloe+bismuth+amoxicillin+clarithromycin; Drug: Vonoprazan+tetracycline+furazolidone 14 days; Drug: Vonoprazan+amoxicillin 7 days

• Registration Number: NCT06168214
• Lead Sponsor: Xijing Hospital of Digestive Diseases

Brief Summary

The goal of this clinical trial is to compare eradication rates of Helicobacter pylori in patients aged 18-70 years with first infection. The main questions it aims to answer are:

* Main indicators: the eradication rate of Helicobacter pylori for eradication.

* Secondary indicators: symptomatic relief rate at 2 weeks after treatment and 4 weeks after the end of treatment; compliance and adverse reactions during treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-04
• Study First Submitted: 2023-11-24
• Study First Submitted QC: 2023-12-12
• Study First Posted: 2023-12-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-13
• Primary Completion: 2024-11-25
• Study Completion: 2024-12-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1404

Inclusion Criteria

• Age 18-70 years, regardless of sex; chronic gastritis, peptic ulcer or dyspeptic symptoms, clear Hp infection (positive 13C-urea breath test); voluntary Hp eradication treatment; women of childbearing age are required to use a medically desirable form of contraception during the trial and for 1 month after the trial.

Exclusion Criteria

• Have contraindications to the study drug or are allergic to the study drug; have taken a PPI within 2 weeks and an antibiotic or bismuth within 4 weeks; pregnant and lactating women; and Have undergone upper gastrointestinal surgery; refluse to sign the informed consent document.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vonoprazan+amoxicillin+tetracycline 14 days	Vonoprazan+amoxicillin+tetracycline 14 days	7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg tid; T: tetracycline 500mg tid.
Vonoprazan+amoxicillin+clarithromycin 14 days	Vonoprazan+amoxicillin+clarithromycin 14 days	14D: V: vonoprazan 20mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid.
Vonoprazan+amoxicillin+clarithromycin 7 days	Vonoprazan+amoxicillin+clarithromycin 7 days	7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid.
Vonoprazan+tetracycline+furazolidone 7 days	Vonoprazan+tetracycline+furazolidone 7 days	7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.
Vonoprazan+amoxicillin+furazolidone 7 days	Vonoprazan+amoxicillin+furazolidone 7 days	7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg tid; F: furazolidone 100mg bid.
Vonoprazan+amoxicillin 14 days	Vonoprazan+amoxicillin 14 days	14D:V: vonoprazan 20mg bid; A:amoxicillin1000mg tid.
Rabeprazloe+bismuth+amoxicillin+clarithromycin 14days	Rabeprazloe+bismuth+amoxicillin+clarithromycin	14D: PPI: Rabeprazole 10mg bid; B: bismuth potassium citrate240mg bid/ colloidal bismuth pectin 300mg bid/ colloidal bismuth tartrate 220mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid.
Vonoprazan+tetracycline+furazolidone 14 days	Vonoprazan+tetracycline+furazolidone 14 days	14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.
Vonoprazan+amoxicillin 7 days	Vonoprazan+amoxicillin 7 days	7D:V: vonoprazan 20mg bid; A:amoxicillin1000mg tid.

Primary Outcome Measures

Name	Time	Method
Eradication rate of Helicobacter pylori	Helicobacter pylori eradication rate assessed 4-8 weeks after completion of treatment	Evaluated by 13C/14C-urea Breath test results and/or monoclonal faecal antigen test results were assessed as negative for successful eradication and positive for negative for successful eradication, positive for failed eradication 13C/14C-urea breath test results and/or monoclonal faecal antigen test results, negative for successful eradication and positive for (assessed by 13C/14C-urea breath test results and/or monoclonal faecal antigen test results, negative for successful eradication, positive for failure).

Secondary Outcome Measures

Name	Time	Method
Treatment compliance	7 or 14 days of treatment	Adherence was analysed according to medication possession ratio (MPR), where taking less than 80% of study drug during any evaluation period or failure to review was considered poor adherence;
Incidence of adverse effects	14 days of treatment, and 28 days after treatment	According to the requirements of the "Drug Clinical Trial Management Code", the observation is carried out, and the adverse reactions of the patients during the administration of the drug are recorded. The severity, or intensity, of an AE refers to the extent to which an AE affects the subject' s daily activities. The intensity of the AE will be rated as mild (discomfort without influencing daily activities), moderate (discomfort partially influencing daily activities), or severe (discomfort with severe interruption with daily activities).
Symptom relief rate	14 days of treatment, and 28 days after treatment	Patients were classified as no change, remission, cure, or exacerbation based on changes in clinical symptoms.

Trial Locations

Locations (1)

Ying han; 🇨🇳 Xi'an, Shaanxi, China