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

Phase 4

• Conditions: Eradication Rate for Helicobacter
• Interventions: Drug: levofloxacin-based sequential therapy; Drug: levofloxacin-based triple therapy for 10 days

• Registration Number: NCT01537055
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-21
• Study First Posted: 2012-02-22
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-30
• Last Update Posted: 2015-02-02
• Primary Completion: 2015-12
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
levofloxacin-based sequential therapy	levofloxacin-based sequential therapy	levofloxacin-based sequential therapy
levofloxacin-based triple therapy	levofloxacin-based triple therapy for 10 days	levofloxacin-based triple therapy for 10 days

Primary Outcome Measures

Name	Time	Method
Eradication rate in the second line therapy	6 weeks	Assessed by UBT

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse effect	2 weeks	during treatment

Trial Locations

Locations (9)

Health Bureau of Lienchiang County; 🇨🇳 Lienchiang, Taiwan

Taipei Veteran General Hospital; 🇨🇳 Taipei, Taiwan

National Taiwan University Hospital, Hsinchu Branch; 🇨🇳 Hsinchu, Taiwan

Mackay Memorial Hospital; 🇨🇳 Taitung Branch, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

E-DA Hospital and I-Shou University; 🇨🇳 Kaohsiung, Taiwan

Kaohsiung Medical University; 🇨🇳 Kaohsiung, Taiwan

National Taiwan University Hospital , Yunlin; 🇨🇳 Yunlin, Taiwan

Taipei Medical University Hospital; 🇨🇳 Taipei, Taiwan