Tegoprazan-Based Therapies for H. Pylori Eradication: A Randomized Controlled Trial

NCT06977841 | Completed

• 1 other identifier: ZYC-Hp2025
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori Eradication; Adverse Reaction

Keywords

Helicobacter pylori; Tegoprazan; Amoxicillin; Tetracycline; Eradication therapy

Outcome Measures

Primary Outcomes (1)

• H. pylori eradication rate

  Assessed by 13C-urea breath test (13C-UBT) at 30 days post-treatment. Eradication success was defined as a negative result (delta over baseline value \<4‰).

  44 days

Secondary Outcomes (2)

• Frequency of the adverse events

  44 days

• Compliance rate of the drugs

  44 days

Study Arms (4)

Tegoprazan-Amoxicillin Dual Therapy

EXPERIMENTAL

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.

Drug: Tegoprazan; Drug: Amoxicillin

Tegoprazan-Tetracycline Dual Therapy

EXPERIMENTAL

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.

Drug: Tegoprazan; Drug: Tetracycline

Tegoprazan-Amoxicillin-Tetracycline Triple Therapy

EXPERIMENTAL

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.

Drug: Tegoprazan; Drug: Amoxicillin; Drug: Tetracycline

Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy

ACTIVE COMPARATOR

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 Potassium Citrate Capsules 300 mg (equivalent to 110 mg bismuth) orally twice daily (BID) after meals; All administered for 14 consecutive days.

Drug: Tegoprazan; Drug: Amoxicillin; Drug: Tetracycline; Drug: Bismuth

Interventions

Tegoprazan DRUG

50 mg twice daily (BID), d1-14.

Tegoprazan-Amoxicillin Dual Therapy; Tegoprazan-Amoxicillin-Tetracycline Triple Therapy; Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy; Tegoprazan-Tetracycline Dual Therapy

Amoxicillin DRUG

In the Tegoprazan-Amoxicillin Dual Therapy group, amoxicillin 750 mg four times daily (QID) on days 1-14; in the Tegoprazan-Amoxicillin-Tetracycline Triple Therapy group and the Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy group, amoxicillin 1000 mg twice daily.

Tegoprazan-Amoxicillin Dual Therapy; Tegoprazan-Amoxicillin-Tetracycline Triple Therapy; Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy

Tetracycline DRUG

In the Tegoprazan-Tetracycline Dual Therapy group, tetracycline tablets 500 mg (Hainan Pharmaceutical Factory Co., Ltd. No. 1 Pharmaceutical Factory) were administered four times daily; in the Tegoprazan-Amoxicillin-Tetracycline Triple Therapy and Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy groups, tetracycline tablets 500 mg were administered three times daily.

Tegoprazan-Amoxicillin-Tetracycline Triple Therapy; Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy; Tegoprazan-Tetracycline Dual Therapy

Bismuth DRUG

In the Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy group, bismuth potassium citrate capsules 300 mg (equivalent to 110 mg bismuth) (Hunan Warner Pharmaceutical Co., Ltd.) were administered twice daily.

Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 70 years;
• H. pylori infection diagnosed by ¹³C-urea breath test and rapid urease test during endoscopy;
• The patient infected with Helicobacter pylori has never undergone eradication therapy.

You may not qualify if:

• Patients with a definite history of allergy to the study drugs (tegoprazan, amoxicillin, tetracycline, or bismuth potassium citrate);
• Those who have used any proton pump inhibitors, potassium-competitive acid blockers, antibiotics, bismuth agents, or H₂ receptor antagonists within 4 weeks prior to enrollment;
• Those with concomitant severe cardiovascular, pulmonary, hepatic, renal, or other systemic diseases (e.g., New York Heart Association functional class III-IV, chronic kidney disease stage 3 or higher, Child-Pugh class B or higher cirrhosis);
• Those requiring long-term use of systemic corticosteroids, anticoagulants, or antiplatelet agents (excluding aspirin \<100 mg daily);
• Pregnant or breastfeeding women;
• Those with a history of drug abuse or alcohol dependence within the past 1 year;
• Those with a current or prior history of malignancy at any site;
• Those with active gastrointestinal bleeding or unexplained iron deficiency anemia;
• Those with severe psychiatric disorders that may compromise compliance with the study;
• Those who have participated in other interventional clinical trials within 3 months prior to enrollment.

Sponsors & Collaborators

• Zhongshan Hospital (Xiamen), Fudan University: lead

Study Sites (1)

Zhongshan Hospital (Xiamen), Fudan University

Xiamen, Fujian, 361015, China

Location

Related Publications (1)

• Nan XP, Zhao HY, Guo LN, Zheng RQ, Wang XL, Wang YF, Su YH, Geng WR, Liu XL, Xu HM, Zhou KL, Guo YT, Cao JH, Han ZX, Kong QZ, Zuo XL, Li YQ, Li YY. Seven-Day Versus 14-Day Tegoprazan and Tetracycline-Containing Quadruple Therapy for First-Line Eradication of Helicobacter pylori Infection: A Randomized, Open-Label, Noninferiority Trial. Helicobacter. 2025 Mar-Apr;30(2):e70036. doi: 10.1111/hel.70036.

  PMID: 40272011 RESULT

MeSH Terms

Interventions

tegoprazan; Amoxicillin; Tetracycline; Bismuth

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals

Study Officials

• Yucheng Zhu, Ph.D.

  Zhongshan Hospital (Xiamen), Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: May 10, 2025
• First Posted: May 18, 2025
• Study Start: June 10, 2025
• Primary Completion: March 10, 2026
• Study Completion: March 10, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)