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

Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Triple Therapy as Second Line Therapy for Refractory Helicobacter Pylori Infection- A Multi-center Randomized Trial

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01537055

Enrollment

600

Registered

2012-02-22

Start date

2012-02-29

Completion date

2016-04-30

Last updated

2015-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eradication Rate for Helicobacter

Keywords

H pylori eradication

Brief summary

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

Detailed 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.

Interventions

DRUGlevofloxacin-based sequential therapy

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)〕

DRUGlevofloxacin-based triple therapy for 10 days

lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Eradication rate in the second line therapy	6 weeks	Assessed by UBT

Secondary

Measure	Time frame	Description
Incidence of adverse effect	2 weeks	during treatment

Countries

Taiwan

Contacts

Primary ContactJyh-Ming Liou, MD

dtmed046@pchome.com.tw886-972651883

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026