Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-26 @ 7:53 AM
Study NCT ID:
NCT04678492
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2020-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Helicobacter Rescue Therapy With High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy
Sponsor:
Xijing Hospital of Digestive Diseases
Organization:
Study Overview
Official Title:
Rescue Therapy for Helicobacter Pylori Eradication: A Randomized and Non-inferiority Trail of High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy
Status:
COMPLETED
Status Verified Date:
2023-01
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:
This study aims at evaluating efficacy and safety of high-dose esomeprazole and amoxicillin dual therapy(esomeprazole and amoxicillin) versus bismuth-containing quadruple Therapy(bismuth，esomeprazole，tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that high-dose esomeprazole and amoxicillin dual therapy is non-inferior to bismuth-containing quadruple Therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
Detailed Description:
The study will include three phases: screening, treatment and follow-up.
Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.
Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 14 and 16.
Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test，rapid urease test or helicobacter pylori stool antigen test.
Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.
Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 14 and 16.
Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test，rapid urease test or helicobacter pylori stool antigen test.
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?: