Efficacy and Safety of Tegoprazan-Amoxicillin and Tegoprazan-Tetracycline Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Current first-line Helicobacter pylori eradication protocols involve multidrug regimens comprising a proton pump inhibitor (PPI) or bismuth agent combined with dual antibiotics (e.g., clarithromycin, amoxicillin, quinolones, furazolidone, nitroimidazoles, or tetracycline) administered for 7-14 days. In China, the bismuth-containing quadruple therapy (BQT) remains the standard first-line treatment for H. pylori infection. However, BQT implementation is challenged by polypharmacy burdens, substantial adverse events, and suboptimal treatment adherence. Emerging evidence suggests that simplified dual therapies pairing acid suppressants (PPIs or potassium-competitive acid blockers \[P-CABs\]) with high-dose amoxicillin achieve comparable eradication rates to BQT while demonstrating superior tolerability and adherence profiles. Notably, the comparative efficacy of tetracycline-based versus amoxicillin-based dual regimens remains unexamined in controlled clinical trials. Our preliminary investigations established that optimized PPI-amoxicillin dual therapy achieves \>90% eradication rates in treatment-naïve populations. Building on these findings, this prospective randomized controlled trial will comparatively assess the effectiveness of tegoprazan-a novel P-CAB exhibiting potent acid inhibition-when co-administered with either amoxicillin or tetracycline in H. pylori-positive adults. The investigation aims to establish an evidence framework for streamlining eradication protocols through pharmacodynamic optimization while mitigating antimicrobial resistance development.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• Age from 18 to 65 years;

• H.pylori infection diagnosed by 13C-urea breath test;

• The patient infected with Helicobacter pylori has never undergone eradication therapy.

Locations
Other Locations
China
Zhongshan Hospital (Xiamen), Fudan University
RECRUITING
Xiamen
Contact Information
Primary
Yucheng Zhu, Ph.D.
zhu.yucheng@zsxmhospital.com
86-592-3501990
Time Frame
Start Date: 2025-06-10
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 87
Treatments
Experimental: Tegoprazan-Amoxicillin Dual Therapy
Tegoprazan 50 mg orally twice daily (BID) before meals; Amoxicillin 750 mg orally four times daily (QID) after meals; Both administered for 14 consecutive days.
Experimental: Tegoprazan-Tetracycline Dual Therapy
Tegoprazan 50 mg orally twice daily (BID) before meals; Tetracycline 500 mg orally four times daily (QID) after meals; Both administered for 14 consecutive days.
Active_comparator: Tegoprazan-Amoxicillin-Tetracycline Triple Therapy
Tegoprazan 50 mg orally twice daily (BID) before meals; Amoxicillin 1 g orally twice daily (BID) after meals; Tetracycline 500 mg orally three times daily (TID) after meals; All administered for 14 consecutive days.
Active_comparator: Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy
Tegoprazan 50 mg orally twice daily (BID) before meals; Amoxicillin 1 g orally twice daily (BID) after meals; Tetracycline 500 mg orally three times daily (TID) after meals; Bismuth agent (bismuth potassium citrate) 220 mg orally twice daily (BID) after meals; All administered for 14 consecutive days.
Related Therapeutic Areas
Sponsors
Leads: Zhongshan Hospital (Xiamen), Fudan University

This content was sourced from clinicaltrials.gov

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