Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Triple Therapy as Second Line Therapy
Information source: National Taiwan University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Eradication Rate for Helicobacter
Intervention: levofloxacin-based sequential therapy (Drug); levofloxacin-based triple therapy for 10 days (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: National Taiwan University Hospital Official(s) and/or principal investigator(s): Jyh-Ming Liou, MD, Principal Investigator, Affiliation: National Taiwan University Hospital
Overall contact: Jyh-Ming Liou, MD, Phone: 886-972651883, Email: dtmed046@pchome.com.tw
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
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Eradication rate in the second line therapy
Secondary outcome: Incidence of adverse effect
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.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Jyh-Ming Liou, MD, Phone: 886-972651883, Email: dtmed046@pchome.com.tw
National Taiwan University Hospital, Hsinchu Branch, Hsinchu, Taiwan; Recruiting Wen-Fong Hsu
E-DA Hospital and I-Shou University, Kaohsiung, Taiwan; Recruiting Chi-yang Chang
Kaohsiung Medical University, Kaohsiung, Taiwan; Recruiting Jeng-Yih Wu
Health Bureau of Lienchiang County, Lienchiang, Taiwan; Recruiting Feng-Yun Tsao
Mackay Memorial Hospital, Taipei, Taiwan; Recruiting Wen-Hsiung Chang
National Taiwan University Hospital, Taipei 10002, Taiwan; Recruiting Jyh-Ming Liou, MD, Phone: 886-972651883, Email: dtmed046@pchome.com.tw
Taipei Medical University Hospital, Taipei, Taiwan; Recruiting Chun-Chao Chang
Taipei Veteran General Hospital, Taipei, Taiwan; Recruiting Jing-Chuan Luo
Mackay Memorial Hospital, Taitung Branch, Taiwan; Recruiting Ming-Jong Bair
National Taiwan University Hospital , Yunlin, Yunlin, Taiwan; Recruiting Chieh-Chang Chen
Additional Information
Related publications: 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.
Starting date: February 2012
Last updated: January 30, 2015
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