Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04769583
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2021-02-18
Brief Title:
14-day Quadruple Therapy Versus Triple Therapy in HP Eradication
Sponsor:
mohamed bouchoucha
Organization:
Les Laboratoires des Médicaments Stériles
Study Overview
Official Title:
A Double Blind Randomized Study for Treatment of Helicobacter Pylori Infection 14-day Non-bismuth Quadruple Therapy Versus Triple Therapy
Status:
COMPLETED
Status Verified Date:
2021-02
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:
HEPRA
Brief Summary:
In this prospective randomized-controlled study treatment-naive H pylori-infected patients are randomized to receive either standard triple therapy or sequential therapy The aim is to compare the efficacy of concomitant quadruple therapy with standard triple therapy as a first line treatment for H pylori infection in Tunisian patients
Detailed Description:
This study includes male and female patients aged between 18 and 65 with documented Hp infection and who have had no previous eradication treatmentThe diagnosis of Hp infection was made through an anatomopathological study Gastric biopsies were taken according to the Sydney protocol two fundics in one pot two antrals and one at the angle of the lesser curve in a second pot The biopsies were studied by an experienced anatomopathologist
The included patients were randomly divided into two treatment groups according to a 1 1 ratio the first group received concomitant quadruple therapy QC combining a double dose PPI esomeprazole 40 mg x 2 per day with the amoxicillin 1 g x 2 per day metronidazole 500 mg x 2 per day and clarithromycin 500 mg x 2 per day for 14 days The second group received triple therapy TT combining a double dose PPI esomeprazole 40 mg x 2 per day with amoxicillin 1 g x 2 per day and clarithromycin 500 mg x 2 per day for 14 days
H pylori eradication was assessed by the 13C-urea breath test 8 weeks after treatment
The included patients were randomly divided into two treatment groups according to a 1 1 ratio the first group received concomitant quadruple therapy QC combining a double dose PPI esomeprazole 40 mg x 2 per day with the amoxicillin 1 g x 2 per day metronidazole 500 mg x 2 per day and clarithromycin 500 mg x 2 per day for 14 days The second group received triple therapy TT combining a double dose PPI esomeprazole 40 mg x 2 per day with amoxicillin 1 g x 2 per day and clarithromycin 500 mg x 2 per day for 14 days
H pylori eradication was assessed by the 13C-urea breath test 8 weeks after treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None