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

NCT ID: NCT01537055

Last Updated: 2015-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-04-30

Brief Summary

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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

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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.

Conditions

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Eradication Rate for Helicobacter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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levofloxacin-based sequential therapy

levofloxacin-based sequential therapy

Group Type EXPERIMENTAL

levofloxacin-based sequential therapy

Intervention Type DRUG

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)〕

levofloxacin-based triple therapy

levofloxacin-based triple therapy for 10 days

Group Type ACTIVE_COMPARATOR

levofloxacin-based triple therapy for 10 days

Intervention Type DRUG

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

Interventions

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levofloxacin-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)〕

Intervention Type DRUG

levofloxacin-based triple therapy for 10 days

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

Intervention Type DRUG

Other Intervention Names

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Takepron Cravit Flagyl Amoxicillin Takepron Cravit Amoxicillin

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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E-DA Hospital

OTHER

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University Hospital

National Taiwan University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jyh-Ming Liou, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital, Hsinchu Branch

Hsinchu, , Taiwan

Site Status RECRUITING

E-DA Hospital and I-Shou University

Kaohsiung City, , Taiwan

Site Status RECRUITING

Kaohsiung Medical University

Kaohsiung City, , Taiwan

Site Status RECRUITING

Health Bureau of Lienchiang County

Lienchiang, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Mackay Memorial Hospital

Taipei, , Taiwan

Site Status RECRUITING

Taipei Medical University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Taipei Veteran General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Mackay Memorial Hospital

Taitung Branch, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital , Yunlin

Yunlin, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Jyh-Ming Liou, MD

Role: CONTACT

886-972651883

Facility Contacts

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Wen-Fong Hsu

Role: primary

Chi-yang Chang

Role: primary

Jeng-Yih Wu

Role: primary

Feng-Yun Tsao

Role: primary

Jyh-Ming Liou, MD

Role: primary

886-972651883

Wen-Hsiung Chang

Role: primary

Chun-Chao Chang

Role: primary

Jing-Chuan Luo

Role: primary

Ming-Jong Bair

Role: primary

Chieh-Chang Chen

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 21632579 (View on PubMed)

Liou 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.

Reference Type DERIVED
PMID: 26832653 (View on PubMed)

Other Identifiers

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201110021MD

Identifier Type: -

Identifier Source: org_study_id

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