THC
Comparison of the Efficacy of Clarithromycin-based Triple Therapy for 14 Days Versus Sequential Therapy for 10 Days in the First Line Therapy for Helicobacter Pylori Infection- A Multicenter Randomized Comparative Trial
Sponsor study identifier
interventional
1,300
1 country
1
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The investigators aimed to compare the eradication rates of sequential therapy for 10 days versus triple therapy for 14 days
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
February 16, 2012
Actual (reported)May 30, 2012
Actual (reported)December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis
C13-UBT will be used to assess the existence of H. pylori
6 weeks
Incidence of adverse effects
during eradication therapy
Sequential therapy
Triple therapy
D1-D5: (lansoprazole 30mg + amoxicillin 1gm) bid D6-D10: (lansoprazole 30mg+clarithromycin 500mg+metronidazole 500mg) bid
D1-D14: (lansoprazole 30mg + clarithromycin 500mg + amoxicillin 1gm) bid
National Taiwan University Hospital
Taipei, 10002, Taiwan
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.
Jyh-Ming Liou, MD
National Taiwan University Hospital
Ming-Shiang Wu, MD, PhD
National Taiwan University Hospital
First Submitted
February 16, 2012
First Posted
May 30, 2012
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 29, 2013
Record last verified: 2013-10
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Source: ClinicalTrials.gov.
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