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Evaluation of clinical therapeutic effect of Vonorazan without bismuth for eradication of Helicobacter pylori

Evaluation of clinical therapeutic effect of Vonorazan without bismuth for eradication of Helicobacter pylori: A prospective multicenter clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061000
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Helicobacter pylori infection

Interventions

PPI bismuth quadruple Group:Esomeprazole 20mg bid + bismuth potassium citrate 220mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid for 14 days
Vonorazan Triple 1 Group:Vonolazan 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid for 14 days
Vonorazan Triple 2 Group:Vonolazan 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid for 10 days

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age 18 to 65 years, male or female; 2.The presence of Hp infection is proved by any one of a C13 or C14 breath test, rapid urease test, or histopathology; 3.Have not received Hp eradication treatment before, that is, the initial treatment; 4.No allergy to penicillin or previous use of amoxicillin; 5.No history of allergy to the drugs in the research protocol; 6.Signed to agree to participate in this study voluntarily, actively cooperate with the follow-up and bear the relevant medical expenses.

Exclusion criteria

Exclusion criteria: 1.Patients with active gastrointestinal bleeding; 2.History of upper gastrointestinal surgery; 3.Pregnant, lactating women and those who are unwilling to take contraceptive measures during the trial; 4.The patient also has other serious diseases that affect the evaluation of this study, such as severe liver disease, lung disease, heart disease, kidney disease, malignant tumor and alcoholism; 5.Patients who cannot express their main complaints correctly, such as mental illness or severe neurosis, cannot cooperate with this trial; 6.Allergy history to the test drug; 7.There are factors considered by other researchers that may affect the accuracy of the test results and the interests of patients.

Design outcomes

Primary

MeasureTime frame
Hp eradication success rate;

Secondary

MeasureTime frame
Patient compliance;The incidence of adverse reactions;Safety;

Countries

China

Contacts

Public ContactZibin Tian

The Affiliated Hospital of Qingdao University

tianzbsun@163.com+86 18661805123

Outcome results

None listed

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