Skip to content

To assess the efficacy, safety and tolerability of vonoprazan, a novelpotassium-competitive acid blocker, as a component of Helicobacter pylori eradication therapy.

To assess the efficacy, safety and tolerability of vonoprazan, a novelpotassium-competitive acid blocker, as a component of Helicobacter pylori eradication therapy.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044683
Enrollment
Unknown
Registered
2021-03-25
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-09-28

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

Conditions

Infection of Helicobacter pylori

Interventions

triple therapy group:VPZ 20 mg bid, amoxicillin 1000 mg bid and clarithromycin 500 mg bid for 2 week
quadruple?therapy group:Esomeprazole 20?mg?as?part?of?first-line?quadruple?therapy

Sponsors

The Affiliated Changzhou No.2 People's Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: Male or female H pylori-positive patients aged >= 20 years with gastric or duodenal ulcer history.

Exclusion criteria

Exclusion criteria: The main exclusion criteria included acute upper GI bleeding, active gastric or duodenal ulcers, acute gastric or duodenal mucosal lesions, previous H pylori eradication therapy, surgery which might affect gastric acid secretion (upper GI resection or vagotomy), Zollinger–Ellison syndrome or other gastric acid hypersecretion disorders, serious neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, GI,urological, endocrinological or haematological disorders, need for surgery, history of drug (including alcohol) abuse, history of malignancy and female subjects who were pregnant or lactating.

Design outcomes

Primary

MeasureTime frame
13C-urea breath tests;

Countries

China

Contacts

Public ContactFan Li

The Affiliated Changzhou No.2 People's Hospital of Nanjing Medical University

158551814@qq.com+86 13815000812

Outcome results

None listed

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