Ignite Creation Date:
2024-05-06 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03342456
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2017-10-30
Brief Title:
The Efficacy and Safety of IlaprazoleDoxycycline-based Bismuth-containing Quadruple Therapy on Hp Infected Duodenal Ulcers
Sponsor:
The Third Xiangya Hospital of Central South University
Organization:
The Third Xiangya Hospital of Central South University
Study Overview
Official Title:
The Efficacy and Safety of IlaprazoleDoxycycline-based Bismuth-containing Quadruple Therapy on Hp Infected Duodenal Ulcers A Randomized Parallel-controlled Multi-center Study
Status:
COMPLETED
Status Verified Date:
2022-02
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:
None
Brief Summary:
Helicobacter pylori Hp infection is one of the important causes of gastrointestinal diseases including gastritis peptic ulcer and malignancies nd the eradication of Hp can effectively cure or prevent these diseases Now owing to the increasingly serious antibiotic resistance Hp eradication rate is however becoming decreased In order to improve the eradication rate of Hp clinicians pay great attention to choose more effective treatment
Ilaprazole Enteric-Coated Tablets is a new generation of proton pump inhibitor PPI Previous research found that Ilaprazole had a more prolonged half-life and higher suppression of gastric acid secretion In addition its metabolism is not significantly influenced by CYP2C19 compared to the available PPIs Doxycycline is in the tetracycline antibiotic class has a stronger antibacterial force than tetracycline and its antibacterial spectrum is basically the same as tetracycline and doxycycline so far it is not widely used Preliminary observations showed that IlaprazoleDoxycycline-based quadruple therapy was effective in treating Hp infection with less adverse reactions and good compliance with patients
In this study a multi-center randomized parallel controlled trial will be conducted in 7 hospitals in Hunan Province China to observe the clinical efficacy and safety of the Bismuth-containing quadruple therapy with Ilaprazole Doxycycline Furazolidone and Bismuth Potassium Citrate in the treatment of Hp infected duodenal ulcer It is expected to complete 200 effective cases including 100 cases in the experimental group and 100 cases in the control group
Ilaprazole Enteric-Coated Tablets is a new generation of proton pump inhibitor PPI Previous research found that Ilaprazole had a more prolonged half-life and higher suppression of gastric acid secretion In addition its metabolism is not significantly influenced by CYP2C19 compared to the available PPIs Doxycycline is in the tetracycline antibiotic class has a stronger antibacterial force than tetracycline and its antibacterial spectrum is basically the same as tetracycline and doxycycline so far it is not widely used Preliminary observations showed that IlaprazoleDoxycycline-based quadruple therapy was effective in treating Hp infection with less adverse reactions and good compliance with patients
In this study a multi-center randomized parallel controlled trial will be conducted in 7 hospitals in Hunan Province China to observe the clinical efficacy and safety of the Bismuth-containing quadruple therapy with Ilaprazole Doxycycline Furazolidone and Bismuth Potassium Citrate in the treatment of Hp infected duodenal ulcer It is expected to complete 200 effective cases including 100 cases in the experimental group and 100 cases in the control group
Detailed Description:
None
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