Clarithromycin-based Triple Therapy for 14 Days Versus Sequential Therapy 10 Days in the First Line Therapy
NCT ID: NCT01607918
Last Updated: 2013-10-29
Study Results
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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UNKNOWN
PHASE4
1300 participants
INTERVENTIONAL
2012-02-29
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sequential therapy 10 days
Sequential therapy
D1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole)
D1-D5: (lansoprazole 30mg + amoxicillin 1gm) bid D6-D10: (lansoprazole 30mg+clarithromycin 500mg+metronidazole 500mg) bid
Triple therapy 14 days
Triple therapy
D1-D14: (lansoprazole + clarithromycin + amoxicillin)
D1-D14: (lansoprazole 30mg + clarithromycin 500mg + amoxicillin 1gm) bid
Interventions
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D1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole)
D1-D5: (lansoprazole 30mg + amoxicillin 1gm) bid D6-D10: (lansoprazole 30mg+clarithromycin 500mg+metronidazole 500mg) bid
D1-D14: (lansoprazole + clarithromycin + amoxicillin)
D1-D14: (lansoprazole 30mg + clarithromycin 500mg + amoxicillin 1gm) bid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consents will be obtained from all patients prior to enrollment.
Exclusion Criteria
* children and teenagers aged less than 20 years,
* history of gastrectomy,
* gastric malignancy, including adenocarcinoma and lymphoma,
* previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin, metronidazole) and prompt pump inhibitors (lansoprazole), - contraindication to treatment drugs,
* pregnant or lactating women,
* severe concurrent disease
* Patients who cannot give informed consent by himself or herself.
20 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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National Taiwan University Hospital
Doctor and Principle Investigator, Department of Gastroenterology
Principal Investigators
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Jyh-Ming Liou, MD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Ming-Shiang Wu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Romano M, Cuomo A, Gravina AG, Miranda A, Iovene MR, Tiso A, Sica M, Rocco A, Salerno R, Marmo R, Federico A, Nardone G. Empirical levofloxacin-containing versus clarithromycin-containing sequential therapy for Helicobacter pylori eradication: a randomised trial. Gut. 2010 Nov;59(11):1465-70. doi: 10.1136/gut.2010.215350.
Liou JM, Chen CC, Chang CY, Chen MJ, Chen CC, Fang YJ, Lee JY, Yang TH, Luo JC, Wu JY, Liou TC, Chang WH, Hsu YC, Tseng CH, Chang CC, Bair MJ, Liu TY, Hsieh CF, Tsao FY, Shun CT, Lin JT, Lee YC, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Sequential therapy for 10 days versus triple therapy for 14 days in the eradication of Helicobacter pylori in the community and hospital populations: a randomised trial. Gut. 2016 Nov;65(11):1784-1792. doi: 10.1136/gutjnl-2015-310142. Epub 2015 Sep 3.
Other Identifiers
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201110019MD
Identifier Type: -
Identifier Source: org_study_id
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