Ignite Creation Date:
2024-05-06 @ 1:45 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01888237
Status:
COMPLETED
Last Update Posted:
2015-04-10
First Post:
2013-06-25
Brief Title:
High Dose PPI Triple Therapy Versus Sequential Therapy for Helicobacter Pylori Eradication
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
Randomized Open Labeled Clinical Trial a Comparative Study of 10-day High Dose PPI-based Triple Therapy vs 10-day Sequential Therapy for Helicobacter Pylori Eradication in Functional Dyspepsia Patients
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the efficacy between 1-day high dose PPI-based triple therapy vs 10-day sequential therapy for Helicobacter pylori eradication in functional dyspepsia patients
Detailed Description:
Background
Helicobacter pylori HP play an important role in the pathogenesis of chronic gastritis peptic ulcer diseases as well as gastric cancer Helicobacter pylori eradication is a critical strategy to reduce aforementioned conditions Proton-pump inhibitor PPI-based triple therapy Standard dose PPIs Clarithromycin 1gD Amoxycillin 2gD or Metronidazole 800 mgD is recommended as a frontline treatment in current guidelines for HP eradication both from Thai and Second Asia-Pacific Consensus Guideline for Hpylori 2009 Unfortunately it has been reported an unacceptably low eradication rate 85 of this regimen in a tertiary care hospital in Thailand This occurrence is not surprised as the worldwide efficacy of this regimen had decreased to 50-75 Of this Clarithromycin resistance has been a major cause of the treatment failure
Sequential therapy ST which consists of standard dose PPIs amoxycillin 2 gD for 5 days with 5 additional days of clarithromycin 1gD metronidazole 800 mgD has been proposed to increase an efficacy in HP eradication A recent meta-analysis of over three thousand population revealed a higher eradication rate over PPI-based triple therapy TT A consistent finding from Thailand was reported an impressive success rate of ST in HP eradication up to 95 Therefore more updated guidelines recommend using ST not TT as the first line regimen However ST is a complicated regimen for the patients to be followed This might cause a low adherence rate in clinical practice as well as development of drug resistance in near future
Interestingly PPI is a pivotal in all regimens in HP eradication There is evidence that the sustained higher intragastric pH is a major therapeutic determinant of HP eradication Other factors including inflammatory cytokine polymorphisms especially the IL-1B-511 TT genotype and PPIs metabolizer are the determinants of eradication by affecting gastric acid secretion and mucosal inflammation Hence higher dosage of PPIs is justified to eradicate HP This has been shown in a recent meta-analysis that high dose PPI is better than standard dose PPI triple therapy in HP eradication of HP Our study aims to compare the efficacy of ST to high dose PPI TT Secondary outcomes include comparisons in the adherence and adverse events between both regimens to determine the prevalence of clarithromycin resistance HP and determine improvement of dyspeptic symptoms after HP eradication
Primary AimObjective
To evaluate eradication rates of Helicobacter pylori infection in functional dyspepsia patients amongst Thai population compare between a 10-day sequential regimen lansoprazole 30 mg bd plus amoxicillin 1000 mg bd for 5 days then lansoprazole 30 mg bd metronidazole 400 mg bd and clarithromycin 500 mg bd for the remaining 5 days with a 10-day high dose PPI-based triple regimen lansoprazole 60 mg bd plus clarithromycin 500 mg bd and amoxycillin 1000 mg bd for 10 days
Helicobacter pylori HP play an important role in the pathogenesis of chronic gastritis peptic ulcer diseases as well as gastric cancer Helicobacter pylori eradication is a critical strategy to reduce aforementioned conditions Proton-pump inhibitor PPI-based triple therapy Standard dose PPIs Clarithromycin 1gD Amoxycillin 2gD or Metronidazole 800 mgD is recommended as a frontline treatment in current guidelines for HP eradication both from Thai and Second Asia-Pacific Consensus Guideline for Hpylori 2009 Unfortunately it has been reported an unacceptably low eradication rate 85 of this regimen in a tertiary care hospital in Thailand This occurrence is not surprised as the worldwide efficacy of this regimen had decreased to 50-75 Of this Clarithromycin resistance has been a major cause of the treatment failure
Sequential therapy ST which consists of standard dose PPIs amoxycillin 2 gD for 5 days with 5 additional days of clarithromycin 1gD metronidazole 800 mgD has been proposed to increase an efficacy in HP eradication A recent meta-analysis of over three thousand population revealed a higher eradication rate over PPI-based triple therapy TT A consistent finding from Thailand was reported an impressive success rate of ST in HP eradication up to 95 Therefore more updated guidelines recommend using ST not TT as the first line regimen However ST is a complicated regimen for the patients to be followed This might cause a low adherence rate in clinical practice as well as development of drug resistance in near future
Interestingly PPI is a pivotal in all regimens in HP eradication There is evidence that the sustained higher intragastric pH is a major therapeutic determinant of HP eradication Other factors including inflammatory cytokine polymorphisms especially the IL-1B-511 TT genotype and PPIs metabolizer are the determinants of eradication by affecting gastric acid secretion and mucosal inflammation Hence higher dosage of PPIs is justified to eradicate HP This has been shown in a recent meta-analysis that high dose PPI is better than standard dose PPI triple therapy in HP eradication of HP Our study aims to compare the efficacy of ST to high dose PPI TT Secondary outcomes include comparisons in the adherence and adverse events between both regimens to determine the prevalence of clarithromycin resistance HP and determine improvement of dyspeptic symptoms after HP eradication
Primary AimObjective
To evaluate eradication rates of Helicobacter pylori infection in functional dyspepsia patients amongst Thai population compare between a 10-day sequential regimen lansoprazole 30 mg bd plus amoxicillin 1000 mg bd for 5 days then lansoprazole 30 mg bd metronidazole 400 mg bd and clarithromycin 500 mg bd for the remaining 5 days with a 10-day high dose PPI-based triple regimen lansoprazole 60 mg bd plus clarithromycin 500 mg bd and amoxycillin 1000 mg bd for 10 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None