NCT05586113

The Efficacy of 10-day or 14-day Course of Bismuth-containing Quadruple Therapy:A Randomized Clinical Trial

The Efficacy of Bismuth-containing Quadruple Therapy in the First-line Treatment of Helicobacter Pylori Infection in 10 Days and 14 Days: a Prospective, Randomized, Controlled Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 398 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of Tegoprazan bismuth-containing quadruple eradication therapy at 6 weeks after treatment, subjects underwent another 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.

Detailed description

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent form, the researchers randomized the subjects in groups: subjects received a 10-day or 14-day course of Tegoprazan bismuth-containing quadruple eradication therapy. The medication of groups are as follows. 6-8 weeks after the eradication treatment, the subjects will review the 13C-urea breath test, and the researcher records the results. After all subjects were tested, the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group were calculated. According to the course of treatment, it is randomized into a 10-day treatment group and a 14-day treatment group. The two groups of bismuth quadruple regimens are the same, as follows: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	10-day Tegoprazan bismuth-containing quadruple therapy	10-day Tegoprazan bismuth-containing quadruple therapy: Tegoprazan（Luo Xin Pharmaceutical Group Co. LTD）50mg bid Amoxicillin (Amoxicillin, United Laboratories Co., LTD) 1000mg bid Tetracycline (Huanan Brand, Guangdong Huanan Pharmaceutical Co. LTD.) 500mg qid Bismuth potassium Citrate (Lizhu Delle, Lizhu Group Pharmaceutical Factory) 2g bid

Timeline

• Start date: 2023-02-06
• Primary completion: 2023-10-31
• Completion: 2023-12-31
• First posted: 2022-10-19
• Last updated: 2023-02-03

Locations

1 site across 1 country: China