Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.

Efficacy and Safety of Keverprazan-minocycline Dual Therapy With Different Treatment Durations Versus Bismuth-based Quadruple Therapy for Helicobacter Pylori Eradication: an Open-label, Multicenter, Randomized, Non-inferiority Trial.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07904429

Enrollment

612

Registered

2026-10-29

Start date

2026-07-15

Completion date

2027-12-30

Last updated

2026-10-29

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

Conditions

Helicobacter Infection

Keywords

H. pylori

Brief summary

This study aims to compare the efficacy and safety of keverprazan-minocycline dual therapy versus bismuth-based quadruple therapy for Helicobacter pylori eradication, focusing on eradication rates, patient adherence, and the incidence of adverse drug reactions.

Interventions

DRUGMinocycline

100 mg oral capsule, twice daily

DRUGKeverprazan

20 mg oral tablet, twice daily

DRUGAmoxicillin

1000 mg oral tablet, twice daily

DRUGColloidal Bismuth Pectin

300 mg oral preparation, twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Age 18-65 years; 2. Positive H. pylori status confirmed by 13C-urea breath test and no prior history of eradication therapy; 3. Voluntary participation and provision of written informed consent

Exclusion criteria

1. Allergy to any study medication (e.g., minocycline, keverprazan, amoxicillin); 2. Confirmed active peptic ulcer disease; 3. Prior history of H. pylori eradication treatment; 4. Use of antibiotics or bismuth agents within 4 weeks before treatment initiation, or use of proton pump inhibitors within 2 weeks; 5. Current use of corticosteroids, nonsteroidal anti-inflammatory drugs, or anticoagulants; 6. History of esophageal or gastric surgery; 7. Pregnancy or lactation; 8. Severe comorbidities, including hepatic, cardiovascular, pulmonary, or renal disease; 9. Alcohol abuse; 10. Gastric mucosa-associated lymphoid tissue lymphoma, malignant tumors, peptic ulcer disease, or bronchial asthma; 11. Concurrent use of specific medications: atazanavir or rilpivirine, tricyclic antidepressants, levodopa, acetaminophen, guaifenesin/dextromethorphan, monoamine oxidase inhibitors, tramadol, or similar agents.

Design outcomes

Primary

Measure	Time frame	Description
eradication rates.	4-6 weeks after completion of the last dose	—
adherence	assessed on day 7，day 10 and day 14 of eradication therapy	follow-up conducted via WeChat or telephone
incidence of Adverse Events	assessed on day 7 ,day 10 and day 14 of eradication therapy	follow-up conducted via WeChat or telephone

Countries

China

Contacts

CONTACTZhenyu Zhang

zzy6565@sina.com18951670222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 30, 2026