NCT07242443

Tegoprazan Plus Amoxicillin BID vs TID Regimens for H. Pylori Eradication（Frequency Adjusted Same-dose Therapy for H. Pylori）

A Randomized Controlled Trial Comparing Tegoprazan 50 mg BID Combined With Amoxicillin 1 g TID Versus Tegoprazan 50 mg BID Combined With Amoxicillin 1.5 g BID for the Eradication of Helicobacter Pylori

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: First People's Hospital of Hangzhou · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate two different tegoprazan-based dual therapy regimens for the treatment of Helicobacter pylori (H. pylori) infection. All participants will receive tegoprazan 50 mg twice daily for 14 days, combined with one of two amoxicillin dosing schedules that contain the same total daily dose of 3 grams of amoxicillin. One group will receive amoxicillin 1 gram three times daily (TID), which is the standard regimen. The other group will receive amoxicillin 1.5 grams twice daily (BID), an alternative schedule that may improve convenience and treatment adherence while maintaining the same total daily antibiotic amount. A total of 240 adults with confirmed H. pylori infection will be randomly assigned to one of the two treatment groups. The main goal of the study is to compare the H. pylori eradication rates between the two regimens. Eradication will be assessed 4 to 8 weeks after completing therapy using a ¹³C-urea breath test. Safety, tolerability, and medication adherence will also be monitored.

Detailed description

Helicobacter pylori (H. pylori) infection is a common and clinically important condition associated with peptic ulcer disease, gastric mucosa-associated lymphoid tissue lymphoma, and gastric cancer. Effective eradication remains essential for reducing long-term complications. Traditional proton pump inhibitor (PPI)-based regimens have faced challenges due to rising antibiotic resistance and suboptimal acid suppression. Tegoprazan is a potassium-competitive acid blocker (P-CAB) that provides rapid, potent, and sustained gastric acid inhibition, which may enhance the effectiveness of amoxicillin-based dual therapy. Amoxicillin resistance remains low in many regions, and its efficacy is closely related to maintaining intragastric pH levels that support bacterial replication. The standard tegoprazan dual therapy uses amoxicillin 1 gram three times daily (TID). However, TID dosing may affect patient adherence, which can influence eradication outcomes. This study explores an alternative regimen: amoxicillin 1.5 grams twice daily (BID). The two regimens deliver the same total daily dose of 3 grams of amoxicillin, but the BID schedule may improve convenience and medication compliance while maintaining appropriate pharmacodynamic exposure. This randomized, controlled clinical trial is designed to compare the eradication efficacy, safety, and tolerability of these two dosing strategies in adults with confirmed H. pylori infection. By evaluating whether a simplified BID regimen can achieve non-inferior or superior eradication rates compared with the standard TID regimen, the study aims to provide evidence that may support more convenient dual therapy options for H. pylori management.

Conditions

• HELICOBACTER PYLORI INFECTIONS

Interventions

Type	Name	Description
DRUG	Tegoprazan 50 mg	Tegoprazan 50 mg administered orally twice daily (BID) for 14 days.
DRUG	Amoxicillin 1 g TID	Amoxicillin 1 gram administered orally three times daily (TID) for 14 days.
DRUG	Amoxicillin 1.5 g BID	Amoxicillin 1.5 grams administered orally twice daily (BID) for 14 days.

Timeline

• Start date: 2025-11-20
• Primary completion: 2026-10-31
• Completion: 2026-12-31
• First posted: 2025-11-21
• Last updated: 2025-11-21

Locations

1 site across 1 country: China