NCT04678492

Helicobacter Rescue Therapy With High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy

Rescue Therapy for Helicobacter Pylori Eradication: A Randomized and Non-inferiority Trail of High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 658 (actual)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aims at evaluating efficacy and safety of high-dose esomeprazole and amoxicillin dual therapy(esomeprazole and amoxicillin) versus bismuth-containing quadruple Therapy(bismuth，esomeprazole，tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that high-dose esomeprazole and amoxicillin dual therapy is non-inferior to bismuth-containing quadruple Therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

Detailed description

The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations. Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 14 and 16. Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test，rapid urease test or helicobacter pylori stool antigen test.

Conditions

• Gastritis
• Dyspepsia
• Helicobacter Pylori Infection
• Gastric Cancer
• Peptic Ulcer

Interventions

Type	Name	Description
DRUG	Esomeprazole	High-dose esomeprazole and amoxicillin dual therapy: given for 14 days at a dose of esomeprazole 40mg 1 tablet TID plus amoxicillin 500 mg 2 capsules TID
DRUG	Amoxicillin	High-dose esomeprazole and amoxicillin dual therapy: given for 14 days at a dose of amoxicillin 500 mg 2 capsules TID plus esomeprazole 40mg 1 tablet TID
DRUG	Bismuth	Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 40 mg 1 tablets BID，tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID
DRUG	Esomeprazole	Bismuth-containing quadruple therapy: given for 14 days at a dose of esomeprazole 40mg 1 tablet BID plus bismuth 110 mg 2 capsules BID，tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID
DRUG	Tetracycline	Bismuth-containing quadruple therapy:given for 14 days at a dose of tetracycline 250mg 2 capsules TID plus furazolidone 100mg 1 tablets BID，esomeprazole 40 mg 1 tablets BID and bismuth 110 mg 2 capsules BID
DRUG	Furazolidone	Bismuth-containing quadruple therapy:given for 14 days at a dose of furazolidone 100mg 1 tablets BID plus tetracycline 250mg 2 capsules TID，esomeprazole 40 mg 1 tablets BID and bismuth 110 mg 2 capsules BID

Timeline

• Start date: 2020-12-20
• Primary completion: 2021-12-20
• Completion: 2021-12-20
• First posted: 2020-12-22
• Last updated: 2023-01-31

Locations

1 site across 1 country: China