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Recruiting
NCT07904429
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Conditions: Helicobacter Infection
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 612
Sponsor: Nanjing First Hospital, Nanjing Medical University
Location: Nanjing First Hospital Nanjing Jiangsu
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07904429). StuddyBuddy aggregates publicly available trial information.