Ignite Creation Date:
2024-05-06 @ 2:04 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04209933
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2019-12-13
Brief Title:
Helicobacter Pylori Eradication With Different Bismuth Quadruple Therapies
Sponsor:
Xijing Hospital of Digestive Diseases
Organization:
Xijing Hospital of Digestive Diseases
Study Overview
Official Title:
Comparison of Efficacy of Bismuth Potassium Citrate Pectin Bismuth Capsules and Pectin Bismuth Granules in the Treatment of Helicobacter Pylori Hp First-line Quadruple Regimen a Multicenter Randomized Prospective Comparative Clinical Trial
Status:
COMPLETED
Status Verified Date:
2021-04
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:
This study aims to compare efficacy and safety of bismuth-containing quadruple therapywith rabeprazole amoxicillin clarithromycinof different kinds of bismuthBismuth potassium citrate pectin bismuth capsules pectin bismuth particlesin H pylori first-line eradication It is hypothesized that different bismuth containing quadruple therapies have comparable eradication efficacy and safety Patients with confirmed H pylori positive status will be randomized to one of the treatments described above At week 2and 6 follow-up visits a urea breath testUBT will be performed to confirm eradication
Detailed Description:
The study will include three phases screening treatment and follow-upScreening this phase will last a maximum of 28 days and subjects eligibility will be evaluated after informed consent signature Endoscopy and Urea Breath test will be performed in addition to the baseline routine evaluationsTreatment 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 12 and 14Follow-up includes two visits approximately 14 days of treatment and 28 days after the end of treatment Eradication of H Pylori will be confirmed through urea breath testUBT
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