NCT05901051

High-dose Dual Therapy with Different Administration Frequencies

Randomized and Controlled Clinical Study of High-dose Dual Therapy with Different Administration Frequencies in the Treatment of Helicobacter Pylori

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 327 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	vonoprazan	Potassium competitive acid blocker
DRUG	Amoxicillin	Antibiotics for H. pylori eradication

Timeline

• Start date: 2021-03-30
• Primary completion: 2023-09-10
• Completion: 2023-09-30
• First posted: 2023-06-13
• Last updated: 2024-12-30

Locations

1 site across 1 country: China