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Efficacy and safety of high-dose ilaprazole dual therapy for Helicobacter pylori eradication: a multicenter, open-label, randomized controlled clinical trial

Efficacy and safety of high-dose ilaprazole dual therapy for Helicobacter pylori eradication: a multicenter, open-label, randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095142
Enrollment
Unknown
Registered
2025-01-02
Start date
2025-01-02
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Helicobacter pylori infection

Interventions

Ilaprazole dual therapy group:High-dose ilaprazole dual therapy
Voronolasan in combination:High-dose vonoprazan dual group

Sponsors

Shenzhen Hospital of Southern Medical Unversity
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age of 18-65 years old (inclusive of the cut-off value), male and female. 2. A positive 13C or 14C-urea breath test within 90 days and the need for Hp eradication therapy. 3. Treatment-naive patients without previous Hp eradication therapy. 4. Gastroscopic diagnosis report within 1 year. 5. No use of antibiotics and bismuth drugs within 30 days before treatment, and no use of PPI, potassium competitive acid blockers, H2 receptor antagonists and other acid inhibitor drugs within 14 days before treatment. 6. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with acute upper gastrointestinal bleeding, gastrointestinal malignant tumor, Zolet-Ellison syndrome, history of esophageal and gastric surgery, reflux esophagitis, gastric ulcer, Crohn's disease, ulcerative colitis. 2. Have serious heart, liver, lung, kidney, blood, endocrine system diseases, and the condition is not under control. 3. Pregnant or lactating women; 4. Ilaprazole or other benzimidazoles, penicillin allergy or idiosyncracies. 5. Participants who participated in other interventional drug clinical trials within 3 months before the trial. 6. Alcoholism or drug addiction. 7. The investigator decided that it was not appropriate to participate in the study for other reasons.

Design outcomes

Primary

MeasureTime frame
H. pylori eradication rate;

Countries

China

Contacts

Public ContactChenye

Southern Medical University Southern Hospital

yechen@smu.edu.cn+86 20 61641543

Outcome results

None listed

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