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Efficacy and Safety of Keverprazan Combined with Different Doses of Amoxicillin Dual Therapy for Eradicating Helicobacter pylori Infection in Elderly Patients: A Prospective Multicenter Randomized Controlled Trial

Efficacy and Safety of Keverprazan Combined with Different Doses of Amoxicillin Dual Therapy for Eradicating Helicobacter pylori Infection in Elderly Patients: A Prospective Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116696
Enrollment
Unknown
Registered
2026-01-14
Start date
2026-01-23
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Helicobacter pylori

Interventions

Keverprazan combined with low-dose amoxicillin group:Keverprazan 20 mg twice daily (bid) plus amoxicillin 1000 mg twice daily (bid)
Keverprazan combined with high-dose amoxicillin group:Keverprazan 20 mg twice daily (bid) plus amoxicillin 1000 mg three times daily (tid)

Sponsors

Northern Jiangsu People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged>= 60 years; 2.Patients with Helicobacter pylori (H. pylori) infection diagnosed by ¹³C/¹4C urea breath test (UBT) or rapid urease test (RUT); 3. Regardless of previous history of H. pylori eradication therapy; 4.Provision of informed consent and voluntary participation in the study.

Exclusion criteria

Exclusion criteria: 1. Individuals who are allergic to the study medication; 2.Those who have used antibiotics, bismuth preparations, and probiotics in the past 4 weeks or potassium-competitive acid blockers (P-CABs), proton pump inhibitors (PPIs), or H2-receptor antagonists in the past 2 weeks; 3. Patients complicated by severe diseases of the heart, liver, lungs, kidneys, or other vital organs, as well as those with immunocompromise; 4. Current pregnancy, lactation, or pregnancy planning; 5. Patients with concomitant gastrointestinal malignancy, or a history of esophageal or gastric surgery; 6. Patients unable to cooperate with the study due to alcoholism, substance abuse, severe mental illness, or other relevant conditions.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication rate ;

Secondary

MeasureTime frame
Adverse events;Compliance;

Countries

China

Contacts

Public ContactBengang Zhou

Northern Jiangsu People's Hospital

zhoubengang198903@126.com+86 180 5106 9350

Outcome results

None listed

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