Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Triple Therapy as Second Line Therapy

National Taiwan University

Status and phase: Unknown; Phase 4

Conditions: Eradication Rate for Helicobacter

Treatments: Drug: levofloxacin-based triple therapy for 10 days; Drug: levofloxacin-based sequential therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01537055

201110021MD

Details and patient eligibility

About

To compare the efficacy and tolerability of levofloxacin-based sequential therapy and triple therapy in the second line therapy for those who fail from one eradication therapy

Full description

About 600 patients who failed from first line triple therapy or sequential therapy will be eligible in this multicenter randomized comparative trial. Eligible patients will be randomized to receive either (1) levofloxacin-based sequential therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g for the first 5 days, followed by lansoprazole 30mg, levofloxacin 250mg, and metronidazole 500mg for another 5 days (all given twice daily)〕or (2) levofloxacin-based triple therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)〕. Eradication will be confirmed with 13C-Urea Breath Test 6 weeks after therapy.

Enrollment: 600 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• H. pylori infected patients who failed from first line therapy will be eligible in this study

Exclusion criteria

• Patients were excluded from the study if any one of the following criteria was present:
• children and teenagers aged less than 20 years,
• history of gastrectomy,
• gastric malignancy, including adenocarcinoma and lymphoma,
• previous allergic reaction to antibiotics (amoxicillin, metronidazole, levofloxacin) and PPI (lansoprazole),
• contraindication to treatment drugs,
• pregnant or lactating women, or
• severe concurrent disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

600 participants in 2 patient groups

levofloxacin-based sequential therapy

Experimental group

Description:

levofloxacin-based sequential therapy

Treatment:

Drug: levofloxacin-based sequential therapy

levofloxacin-based triple therapy

Active Comparator group

Description:

levofloxacin-based triple therapy for 10 days

Treatment:

Drug: levofloxacin-based triple therapy for 10 days