Helicobacter Rescue Therapy With High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy
Condition: Gastritis; Dyspepsia; Helicobacter Pylori Infection; Gastric Cancer; Peptic Ulcer
MeSH terms: Gastritis; Peptic Ulcer; Dyspepsia
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Esomeprazole; Amoxicillin; Bismuth; Esomeprazole; Tetracycline; Furazolidone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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; 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; 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; 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; 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; 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
Other intervention name(s): Nexium; Amoxy; Nexium
Intervention MeSH terms: Amoxicillin; Tetracycline; Furazolidone; Esomeprazole; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; High-dose dual therapy; Bismuth-combining quadruple therapy