Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-30 @ 8:37 AM
Study NCT ID:
NCT05614934
Status:
COMPLETED
Last Update Posted:
2025-02-21
First Post:
2022-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vonoprazan-based Therapy Versus Standard Regimen for Helicobacter Pylori Infection Management
Sponsor:
Alexandria University
Organization:
Study Overview
Official Title:
Vonoprazan-based Therapy Versus Standard Regimen for Helicobacter Pylori Infection Management
Status:
COMPLETED
Status Verified Date:
2022-11
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:
Appropriately, half of the global population is infected with H. pylori, and it is now recognized that it causes at least 95% of all gastric cancers. Currently, the main challenge in the field of H. pylori infection is the rapidly increasing antibiotic resistance worldwide, which is causing a decline in the effectiveness of currently available eradication regimens.
The aim of the study is to assess the safety and efficacy of different H. pylori vonoprazan-based regimens compared to the commonly used standard triple therapy composed of Clarithromycin, Amoxicillin, and Proton pump inhibitor to eradicate H. pylori infection in treatment-naive patients through the determination of each regimen eradication rate and reported safety profile
The aim of the study is to assess the safety and efficacy of different H. pylori vonoprazan-based regimens compared to the commonly used standard triple therapy composed of Clarithromycin, Amoxicillin, and Proton pump inhibitor to eradicate H. pylori infection in treatment-naive patients through the determination of each regimen eradication rate and reported safety profile
Detailed Description:
1. Ethical committee approval is obtained from Ethics committee of Faculty of Medicine, Alexandria University.
2. All participants should agree to take part in this clinical study and will provide informed consent.
3. Patients with suspected H. pylori infection are recruited from Alexandria University out-patient clinics
4. Participants' demographic data, Full medical and medication history, and detailed clinical presentation is documented
5. Participants are tested for H. pylori infection using rapid H. pylori stool antigen test device
6. Negative subjects are excluded while positive patients are randomly allocated to 3 groups of different H. pylori regimens (Standard triple, Vonoprazan dual, and Vonoprazan triple)
7. Following up treatment side effects while taking the medications.
8. Assessing regimens effectiveness through patient retesting at least 1 month after treatment completion.
9. Assessing patient compliance to different regimens during the final visit.
10. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
11. Results, conclusion, discussion and recommendations will be given.
2. All participants should agree to take part in this clinical study and will provide informed consent.
3. Patients with suspected H. pylori infection are recruited from Alexandria University out-patient clinics
4. Participants' demographic data, Full medical and medication history, and detailed clinical presentation is documented
5. Participants are tested for H. pylori infection using rapid H. pylori stool antigen test device
6. Negative subjects are excluded while positive patients are randomly allocated to 3 groups of different H. pylori regimens (Standard triple, Vonoprazan dual, and Vonoprazan triple)
7. Following up treatment side effects while taking the medications.
8. Assessing regimens effectiveness through patient retesting at least 1 month after treatment completion.
9. Assessing patient compliance to different regimens during the final visit.
10. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
11. Results, conclusion, discussion and recommendations will be given.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: