NCT07068607 Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial
| NCT ID | NCT07068607 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Yongquan Shi |
| Condition | Gastritis, Indigestion, Helicobacter Pylori Infection, Gastric Cancer, Peptic Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 400 participants in total. It began in 2025-04-01 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to evaluate the efficacy of vonoprazan combined with different antibiotics in dual therapy for Helicobacter pylori eradication treatment. Newly infected patients were randomly assigned to four groups: amoxicillin dual therapy, tetracycline dual therapy, minocycline dual therapy, and bismuth quadruple therapy. At the follow - up visit in the 6th week, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be conducted to confirm eradication.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 - 70 years, regardless of gender; 2. Patients with definite Hp infection (positive result in any one of the 13C/14C urea breath test, rapid urease test, and fecal Hp antigen test) who have never received Helicobacter pylori eradication treatment; 3. For women of child - bearing age, it is required to use medically acceptable contraceptive methods during the trial period and within 30 days after the end of the trial. Exclusion Criteria: 1. Patients who have been definitely diagnosed with Hp infection and have received antibiotic eradication treatment; 2. Patients with contraindications to the study drug or who are allergic to the study drug; 3. Patients with severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases; 4. Patients who have been continuously using anti - ulcer drugs (including taking PPI within 2 weeks before the Hp infection test), antibiotics or bismuth complexes (more than 3 times a week within 1 month before screening); 5. Pregnant and lactating women; 6. Patients who have undergone upper gastrointestinal surgery; 7. Patients with moderate or severe atypical hyperplasia or high - grade intraepithelial neoplasia; 8. Patients with symptoms of dysphagia; 9. Patients with evidence of bleeding or iron - deficiency anemia; 10. Patients with a history of malignant tumors; 11. Patients with a history of drug or alcohol abuse within the past 1 year; 12. Patients who are using systemic glucocorticoids, non - steroidal anti - inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except for using aspirin ≤ 100 mg/d); 13. Patients with mental disorders; 14. Patients who have participated in other clinical trials within the past 3 months; 15. Patients who refuse to sign the informed consent form.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07068607 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Gastritis, Indigestion, Helicobacter Pylori Infection, Gastric Cancer, Peptic Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07068607 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07068607 currently recruiting?
Yes, NCT07068607 is actively recruiting participants. Contact the research team at shiyquan@fmmu.edu.cn for enrollment information.
Where is the NCT07068607 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT07068607 clinical trial?
NCT07068607 is sponsored by Yongquan Shi. The trial plans to enroll 400 participants.
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