Ignite Creation Date:
2024-05-06 @ 1:14 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01760824
Status:
COMPLETED
Last Update Posted:
2013-01-04
First Post:
2012-12-29
Brief Title:
Quadruple Versus Sequential Therapy for Helicobacter Pylori Eradication
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Ten Days Quadruple Versus Sequential Therapy as Empirical First and Second Line Treatment for Helicobacter Pylori Eradication a Randomized Crossover Trial
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Helicobacter pylori HP a bacterium present in many peoples stomachs is one of the major causes of ulcers and cancers Up to 20 of patients infected with H pylori may develop peptic ulcers However failure rate is rising due to multiple resistant H pylori infection The eradication rate of first line clarithromycin based therapy has fallen to below 80 Both quadruple and sequential treatment regime has been proposed as the first-line empirical regime Nevertheless comparison in terms of efficacy and side effects between the two regime remained unknown The aim of this clinical trial is to compare the efficacy and tolerability of H pylori eradication with a 10-day quadruple therapy versus sequential therapy as empirical first and second line treatment
Detailed Description:
Helicobacter pylori HP a bacterium present in many peoples stomachs is one of the major causes of ulcers and cancers Up to 20 of patients infected with HP may develop peptic ulcers However failure rate is rising due to multiple resistant HP infection The eradication rate of first line clarithromycin based therapy has fell to below 80 and increasing number of patients also failed the second line quadruple therapy The aim of this clinical trial is to compare the efficacy and tolerability of H pylori eradication with a 10-day quadruple therapy versus sequential therapy as empirical first and second line treatment
Methods Eligible H pylori positive patients were randomized to receive either QUAD esomeprazole 20mg twice daily bismuth subcitrate 120mg four times daily tetracycline 500mg four times daily and metronidazole 400mg four times daily for 10 days or SEQ esomeprazole 20mg twice daily for 10 days amoxicillin 1g twice daily for first 5 days clarithromycin 500mg twice daily and metronidazole 400mg four time daily for the subsequent 5 days All patients returned 8 weeks after completing the treatment for a Urea Breath Test UBT to confirm eradication Patients who failed their respective therapy were crossover to receive the alternative regimen
Methods Eligible H pylori positive patients were randomized to receive either QUAD esomeprazole 20mg twice daily bismuth subcitrate 120mg four times daily tetracycline 500mg four times daily and metronidazole 400mg four times daily for 10 days or SEQ esomeprazole 20mg twice daily for 10 days amoxicillin 1g twice daily for first 5 days clarithromycin 500mg twice daily and metronidazole 400mg four time daily for the subsequent 5 days All patients returned 8 weeks after completing the treatment for a Urea Breath Test UBT to confirm eradication Patients who failed their respective therapy were crossover to receive the alternative regimen
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