- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01537055
Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Triple Therapy as Second Line Therapy
January 30, 2015 updated by: National Taiwan University Hospital
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
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
600
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jyh-Ming Liou, MD
- Phone Number: 886-972651883
- Email: dtmed046@pchome.com.tw
Study Locations
-
-
-
Hsinchu, Taiwan
- Recruiting
- National Taiwan University Hospital, Hsinchu Branch
-
Contact:
- Wen-Fong Hsu
-
Kaohsiung, Taiwan
- Recruiting
- E-DA Hospital and I-Shou University
-
Contact:
- Chi-yang Chang
-
Kaohsiung, Taiwan
- Recruiting
- Kaohsiung Medical University
-
Contact:
- Jeng-Yih Wu
-
Lienchiang, Taiwan
- Recruiting
- Health Bureau of Lienchiang County
-
Contact:
- Feng-Yun Tsao
-
Taipei, Taiwan
- Recruiting
- Taipei Medical University Hospital
-
Contact:
- Chun-Chao Chang
-
Taipei, Taiwan, 10002
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Jyh-Ming Liou, MD
- Phone Number: 886-972651883
- Email: dtmed046@pchome.com.tw
-
Taipei, Taiwan
- Recruiting
- Mackay Memorial Hospital
-
Contact:
- Wen-Hsiung Chang
-
Taipei, Taiwan
- Recruiting
- Taipei Veteran General Hospital
-
Contact:
- Jing-Chuan Luo
-
Taitung Branch, Taiwan
- Recruiting
- Mackay Memorial Hospital
-
Contact:
- Ming-Jong Bair
-
Yunlin, Taiwan
- Recruiting
- National Taiwan University Hospital , Yunlin
-
Contact:
- Chieh-Chang Chen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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)〕
Other Names:
|
Active Comparator: levofloxacin-based triple therapy
levofloxacin-based triple therapy for 10 days
|
lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eradication rate in the second line therapy
Time Frame: 6 weeks
|
Assessed by UBT
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse effect
Time Frame: 2 weeks
|
during treatment
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jyh-Ming Liou, MD, National Taiwan University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
April 1, 2016
Study Registration Dates
First Submitted
February 16, 2012
First Submitted That Met QC Criteria
February 21, 2012
First Posted (Estimate)
February 22, 2012
Study Record Updates
Last Update Posted (Estimate)
February 2, 2015
Last Update Submitted That Met QC Criteria
January 30, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Gastrointestinal Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Cytochrome P-450 CYP1A2 Inhibitors
- Anti-Infective Agents, Urinary
- Renal Agents
- Dexlansoprazole
- Lansoprazole
- Amoxicillin
- Levofloxacin
- Ofloxacin
Other Study ID Numbers
- 201110021MD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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