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Tegoprazan and low-or high-dose amoxicillin dual therapy versus bismuth-containing quadruple therapy for helicobacter pylori eradication: a multicenter, open, randomized, noninferiority study

Tegoprazan and low-or high-dose amoxicillin dual therapy versus bismuth-containing quadruple therapy for helicobacter pylori eradication: a multicenter, open, randomized, noninferiority study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089979
Enrollment
Unknown
Registered
2024-09-20
Start date
2025-03-29
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection

Interventions

Low-dose doublet group:Amoxicillin (1 g bid) Tegolasan (50 mg tid) for 14 days
High-dose doublet group:Amoxicillin (1 g tid) Tegolasan (50 mg tid), 14 days
Bismuth tetrapty group:Amoxicillin (1 g bid) Clarithromycin (500 mg bid) Neixin (20 mg bid) Livzon Dele (220 mg bid), 14 days

Sponsors

The first affiliated hostipal of nanchang university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18–70 years; 2.H. pylori-infected subjects ages without eradication history; 3.The confirmation of H. pylori-infected was evaluated by by positive 13C urea breath test; 4.Signed informed consent.

Exclusion criteria

Exclusion criteria: 1.H. pylori-infected subjects ages with eradication history; 2.allergy to amoxicillin or other drugs in the study; 3.Zollinger-Ellison syndrome; 4.acute upper gastrointestinal bleeding, gastric cancer, or other tumors;qid; 5.history of gastric surgery; 6.serious illness including neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrinological or hematological disorders; 7.With serious abnormal liver or renal function; 8.proton pump inhibitors and antibiotics used within one month; 9.pregnancy or lactating women; 10.participated in other clinical trials within 30 days before screening; 11.other factors were considered not suitable.

Design outcomes

Primary

MeasureTime frame
The efficacy of therapy;

Secondary

MeasureTime frame
Incidence of adverse events;Compliance;Clarithromycin resistance rate;Levofloxacin resistance rate;Factors influencing the efficacy of eradication;Effects of gut microbiota;

Countries

China

Contacts

Public ContactYin Zhu

The first affiliated hostipal of nanchang university

zhuyin27@sina.com+86 139 7084 1464

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026