Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Triple Therapy as Second Line Therapy
1 other identifier
interventional
600
1 country
10
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2012
Longer than P75 for phase_4
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 16, 2012
CompletedFirst Posted
Study publicly available on registry
February 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedFebruary 2, 2015
January 1, 2015
3.8 years
February 16, 2012
January 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Eradication rate in the second line therapy
Assessed by UBT
6 weeks
Secondary Outcomes (1)
Incidence of adverse effect
2 weeks
Study Arms (2)
levofloxacin-based sequential therapy
EXPERIMENTALlevofloxacin-based sequential therapy
levofloxacin-based triple therapy
ACTIVE COMPARATORlevofloxacin-based triple therapy for 10 days
Interventions
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)〕
lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)
Eligibility Criteria
You may qualify if:
- H. pylori infected patients who failed from first line therapy will be eligible in this study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Taiwan University Hospitallead
- E-DA Hospitalcollaborator
Study Sites (10)
National Taiwan University Hospital, Hsinchu Branch
Hsinchu, Taiwan
E-DA Hospital and I-Shou University
Kaohsiung City, Taiwan
Kaohsiung Medical University
Kaohsiung City, Taiwan
Health Bureau of Lienchiang County
Lienchiang, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Taipei Veteran General Hospital
Taipei, Taiwan
Mackay Memorial Hospital
Taitung Branch, Taiwan
National Taiwan University Hospital , Yunlin
Yunlin, Taiwan
Related Publications (2)
Liou JM, Chen CC, Chen MJ, Chang CY, Fang YJ, Lee JY, Sheng WH, Wang HP, Wu MS, Lin JT. Empirical modified sequential therapy containing levofloxacin and high-dose esomeprazole in second-line therapy for Helicobacter pylori infection: a multicentre clinical trial. J Antimicrob Chemother. 2011 Aug;66(8):1847-52. doi: 10.1093/jac/dkr217. Epub 2011 May 31.
PMID: 21632579BACKGROUNDLiou JM, Bair MJ, Chen CC, Lee YC, Chen MJ, Chen CC, Tseng CH, Fang YJ, Lee JY, Yang TH, Luo JC, Wu JY, Chang WH, Chang CC, Chen CY, Chen PY, Shun CT, Hsu WF, Hung HW, Lin JT, Chang CY, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Levofloxacin Sequential Therapy vs Levofloxacin Triple Therapy in the Second-Line Treatment of Helicobacter pylori: A Randomized Trial. Am J Gastroenterol. 2016 Mar;111(3):381-7. doi: 10.1038/ajg.2015.439. Epub 2016 Feb 2.
PMID: 26832653DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jyh-Ming Liou, MD
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- National Taiwan University Hospital
Study Record Dates
First Submitted
February 16, 2012
First Posted
February 22, 2012
Study Start
February 1, 2012
Primary Completion
December 1, 2015
Study Completion
April 1, 2016
Last Updated
February 2, 2015
Record last verified: 2015-01