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A Randomized, Non-Inferiority Trial Comparing Kaprazan-Based versus Vonoprazan-Based Dual Therapy with High-Dose Amoxicillin for H. pylori Eradication

A Randomized, Non-Inferiority Trial Comparing Kaprazan-Based versus Vonoprazan-Based Dual Therapy with High-Dose Amoxicillin for H. pylori Eradication

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124468
Enrollment
Unknown
Registered
2026-05-12
Start date
2026-05-12
Completion date
Unknown
Last updated
2026-05-18

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

Conditions

Helicobacter pylori infection

Interventions

Vonoprazan Dual-Therapy Group:Vonoprazan Combined with High-Dose Amoxicillin
Kaprazan Dual-Therapy Group:Kaprazan in Combination with High-Dose Amoxicillin

Sponsors

The First Affiliated Hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 70 years. 2.Confirmed H. pylori infection by at least one of the following methods: ¹³C- or ¹4C-urea breath test; immunohistochemical staining of histopathology; H. pylori culture; rapid urease test; stool H. pylori antigen test. 3.Patients undergoing initial (first-line) H. pylori eradication therapy. 4.Willing to undergo H. pylori treatment and having provided written informed consent.

Exclusion criteria

Exclusion criteria: 1.Known allergy or hypersensitivity to any drug used in the treatment regimen. 2.History of gastric surgery or anatomical abnormalities of the gastrointestinal tract. 3.Patients with active peptic ulcer complicated by hemorrhage or presenting with signs indicative of a high risk for gastrointestinal bleeding. 4.Patients with severe dysfunction of major organ systems (e.g., respiratory, cardiac, hepatic, or renal). 5.Use of bismuth preparations, antibiotics, or antibacterial Chinese herbal medicines within 4 weeks prior to enrollment; or use of potassium-competitive acid blockers (P-CABs), proton pump inhibitors (PPIs), H2-receptor antagonists, or non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to treatment initiation. 6.Concurrent use of clopidogrel or strong inhibitors/inducers of the cytochrome P450 3A4 (CYP3A4) enzyme. 7.Pregnant or lactating women. 8.Individuals with alcohol abuse, substance addiction, or severe neurocognitive disorders.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication rate;

Secondary

MeasureTime frame
Incidence of Adverse Reactions;Compliance;

Countries

China

Contacts

Public ContactHuang Weifeng

The First Affiliated Hospital of Xiamen University

hwf0625@163.com+86 18150906129

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026