High-dose Dual Therapy with Different Administration Frequencies

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: vonoprazan; Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT05901051

rjyy20210815

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 327 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability and willingness to participate in the study and to sign and give informed consent
• Confirmed H. pylori infection

Exclusion criteria

• Pregnant and lactating women;
• History of gastrointestinal malignancies;
• History of previous subtotal gastrectomy;
• Serious dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases; Such as grade IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson disease, etc;
• History of hematological diseases
• People who are allergic to drugs;
• The guardian or patient refused to join the group;
• Alcohol and / or drug abuse (addiction or dependence) or poor compliance judged by doctors;
• No legal capacity or poor self-knowledge
• administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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327 participants in 3 patient groups

dual therapy A

Experimental group

Description:

Vonoprazan 20mg bid ac and amoxicillin 0.75g qid pc

Treatment:

Drug: Amoxicillin

Drug: vonoprazan

dual therapy B

Experimental group

Description:

Vonoprazan 20mg bid ac and amoxicillin 1g tid pc

Treatment:

Drug: Amoxicillin

Drug: vonoprazan

dual therapy C

Experimental group

Description:

Vonoprazan 20mg bid ac and amoxicillin 1g tid ac

Treatment:

Drug: Amoxicillin

Drug: vonoprazan