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Comparison of bismuth quadruple regimen based on keprasen hydrochloride and bismuth quadruple regimen based on esomeprazole for eradication of Helicobacter pylori: A randomized, controlled, open-label, non-inferiority clinical study

Comparison of bismuth quadruple regimen based on keprasen hydrochloride and bismuth quadruple regimen based on esomeprazole for eradication of Helicobacter pylori: A randomized, controlled, open-label, non-inferiority clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108329
Enrollment
Unknown
Registered
2025-08-28
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Helicobacter pylori

Interventions

Keverprazan HydrochlorideTablets group:Amoxicillin 1000mg, twice a day + Levofloxacin Tablets 0.5g, once a day + Keverprazan Hydrochloride 20mg, twice a day + Colloidal Pectin Bismuth 200mg, twice a d
Esomeprazole group:Amoxicillin 1000mg, twice a day + Levofloxacin Tablets 0.5g, once a day + Esomeprazole 20mg, twice a day + Colloidal Bismuth Subcitrate 200mg, twice a day

Sponsors

The Air Force Hospital of Northern Theater PLA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Patients with Hp infection who have been eradicated for the first time; (2) Age: 18 to 70 years old, gender not limited; (3) Women are required to use medically feasible contraceptive methods during the trial period and within 30 days after the trial ends.

Exclusion criteria

Exclusion criteria: (1) Patients with contraindications to the investigational drug or those allergic to the investigational drug; (2) Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable heart, lung or endocrine diseases; (3) Continuous use of anti-ulcer drugs (including taking PPI within 2 weeks before the Hp infection test), antibiotics or bismuth complexes (more than 3 times per week one month before screening); (4) Pregnant and lactating women; (5) Has undergone upper gastrointestinal tract surgery; (6) Suffering from Barrett's esophagus or highly atypical hyperplasia, with symptoms of dysphagia; (7) There is evidence of bleeding or iron deficiency anemia; (8) Have a history of malignant tumors; (9) There is a history of drug or alcohol abuse within the past year; (10) Systemic application of glucocorticoids, non-steroidal anti-inflammatory drugs, anticoagulants, and platelet aggregation inhibitors (except for aspirin =100 mg/d); (11) Those with mental disorders; (12) Has undergone other clinical trials within the past three months; (13) Refuse to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication rate;Clinical symptom improvement status;

Countries

People's Republic of China

Contacts

Public ContactShao Lichun

The Air Force Hospital of Northern Theater PLA

slc700214@163.com+86 1332446933

Outcome results

None listed

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