Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-16 @ 11:13 AM
Study NCT ID:
NCT07242456
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Head-to-head Study of Tegoprazan 50 mg BID Plus Amoxicillin 1 g TID vs. Vonoprazan 20 mg BID Plus Amoxicillin 1 g TID for H. Pylori Eradication
Sponsor:
First People's Hospital of Hangzhou
Organization:
Study Overview
Official Title:
Head-to-head Comparison of Tegoprazan 50 mg BID Plus Amoxicillin 1 g TID Versus Vonoprazan 20 mg BID Plus Amoxicillin 1 g TID for Helicobacter Pylori Eradication: A Randomized, Open-label, Parallel-group Study
Status:
RECRUITING
Status Verified Date:
2025-01
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:
TV-HP
Brief Summary:
This study is a randomized, open-label, parallel-group clinical trial designed to compare two 14-day dual therapies for the eradication of Helicobacter pylori (H. pylori) infection. Participants will be randomly assigned to receive either tegoprazan 50 mg twice daily plus amoxicillin 1 g three times daily, or vonoprazan 20 mg twice daily plus amoxicillin 1 g three times daily.
The primary purpose of this study is to evaluate whether the tegoprazan-based regimen is non-inferior to the vonoprazan-based regimen in terms of H. pylori eradication rates. Eradication will be assessed 4 to 8 weeks after completing therapy using a \^13C-urea breath test. Secondary objectives include assessing treatment-related adverse events, tolerability, and medication adherence.
This study involves adult participants with confirmed H. pylori infection. All study medications are orally administered, and both regimens use drugs with well-established safety profiles. The study is investigator-initiated and conducted at Hangzhou First People's Hospital.
The primary purpose of this study is to evaluate whether the tegoprazan-based regimen is non-inferior to the vonoprazan-based regimen in terms of H. pylori eradication rates. Eradication will be assessed 4 to 8 weeks after completing therapy using a \^13C-urea breath test. Secondary objectives include assessing treatment-related adverse events, tolerability, and medication adherence.
This study involves adult participants with confirmed H. pylori infection. All study medications are orally administered, and both regimens use drugs with well-established safety profiles. The study is investigator-initiated and conducted at Hangzhou First People's Hospital.
Detailed Description:
This investigator-initiated, randomized, open-label, parallel-group study is designed to compare two potassium-competitive acid blocker (P-CAB)-based dual therapies for the eradication of Helicobacter pylori (H. pylori) infection. The study evaluates a 14-day regimen of tegoprazan 50 mg twice daily combined with amoxicillin 1 g three times daily versus a 14-day regimen of vonoprazan 20 mg twice daily combined with amoxicillin 1 g three times daily.
H. pylori infection is a major cause of chronic gastritis, peptic ulcer disease, and gastric cancer. Rising antimicrobial resistance and variable acid suppression with conventional proton pump inhibitors (PPIs) have highlighted the need for alternative treatment strategies. P-CABs, including tegoprazan and vonoprazan, provide rapid, potent, and sustained acid suppression and may enhance the efficacy of high-dose amoxicillin dual therapy. Despite their increasing clinical use, head-to-head comparative evidence between different P-CAB-based dual therapies is limited.
The primary objective of this study is to determine whether the tegoprazan-based dual regimen is non-inferior to the vonoprazan-based dual regimen in terms of H. pylori eradication rate, assessed by a \^13C-urea breath test performed 4 to 8 weeks after treatment completion. Secondary assessments include treatment-emergent adverse events, serious adverse events, gastrointestinal symptom changes, and medication adherence.
Eligible participants are adults with confirmed H. pylori infection who have not received recent eradication therapy or antibiotics with anti-H. pylori activity. The study drugs have established safety profiles and are administered orally. Participants will be randomized in a 1:1 ratio and followed until completion of eradication testing and safety assessments. Data will be analyzed using both intention-to-treat and per-protocol populations.
This study is conducted at Hangzhou First People's Hospital and is intended to provide direct comparative data to guide the selection of P-CAB-based dual therapy regimens in clinical practice.
H. pylori infection is a major cause of chronic gastritis, peptic ulcer disease, and gastric cancer. Rising antimicrobial resistance and variable acid suppression with conventional proton pump inhibitors (PPIs) have highlighted the need for alternative treatment strategies. P-CABs, including tegoprazan and vonoprazan, provide rapid, potent, and sustained acid suppression and may enhance the efficacy of high-dose amoxicillin dual therapy. Despite their increasing clinical use, head-to-head comparative evidence between different P-CAB-based dual therapies is limited.
The primary objective of this study is to determine whether the tegoprazan-based dual regimen is non-inferior to the vonoprazan-based dual regimen in terms of H. pylori eradication rate, assessed by a \^13C-urea breath test performed 4 to 8 weeks after treatment completion. Secondary assessments include treatment-emergent adverse events, serious adverse events, gastrointestinal symptom changes, and medication adherence.
Eligible participants are adults with confirmed H. pylori infection who have not received recent eradication therapy or antibiotics with anti-H. pylori activity. The study drugs have established safety profiles and are administered orally. Participants will be randomized in a 1:1 ratio and followed until completion of eradication testing and safety assessments. Data will be analyzed using both intention-to-treat and per-protocol populations.
This study is conducted at Hangzhou First People's Hospital and is intended to provide direct comparative data to guide the selection of P-CAB-based dual therapy regimens in clinical practice.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| BCF-LX-XH-20221014-26 | OTHER_GRANT | Bethune Charitable Foundation | View |