A RCT of the Efficacy of Vonoprazan 20mg QD in the Treatment of Helicobacter Pylori Infection

NCT05590286 | Unknown Phase 4

• 1 other identifier: 2022-183
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment of helicobacter pylori is very important. The routine treatment is quadruple therapy. In recent years, double therapy has appeared and the curative effect is fair. However, antacid generally uses proton pump inhibitor. The proton pump inhibitor needs double dose to achieve good antacid curative effect. The effect of vonoprazan used for inhibiting gastric acid is better than proton pump inhibitor. At present, many studies use vonoprazan instead of common proton pump inhibitor, but almost all use double dose of vonoprazan. In the previous study, we found that the effect of double dose of proton pump inhibitor can be achieved with 20mg QD of vonoprazan. Therefore, in this study, 20mg QD of vonoprazan was used to replace the double dose of proton pump inhibitor to observe the antibacterial effect of vonoprazan on Helicobacter pylori.

Conditions

Vonoprazan; Helicobacter Pylori Infection; Proton Pump Inhibitor

Keywords

vonoprazan; Helicobacter Pylori; Proton pump inhibitor

Outcome Measures

Primary Outcomes (1)

• Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post-Treatment

  HP infection status will be determined by \^13C Urea Breath Test (\^13C-UBT). The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory.

  Week 4 post-treatment

Study Arms (2)

vonoprazan 20mg QD

EXPERIMENTAL

Vonoprazan 20 mg, tablets, orally, qd given in combination with amoxicillin 750mg capsules, orally, qid for up to 2 weeks.

Drug: Vonoprazan Tablets; Drug: Amoxicillin Capsules

esomeprazole 20 mg BID

ACTIVE COMPARATOR

esomeprazole 20 mg, tablets, orally, bid given in combination with amoxicillin 1000mg，clarithromycin 500mg bid，colloidal bismuth pectin 200mg bid for up to 2 weeks. OR esomeprazole 20 mg, tablets, orally, bis in die given in combination with amoxicillin 750mg capsules, orally, quarter die for up to 2 weeks.

Drug: Amoxicillin Capsules; Drug: Esomeprazole

Interventions

Vonoprazan Tablets DRUG

Vonoprazan 20 mg, tablets, orally，QD

vonoprazan 20mg QD

Amoxicillin Capsules DRUG

Amoxicillin 750mg, Capsules ,orally，QID

esomeprazole 20 mg BID; vonoprazan 20mg QD

Esomeprazole DRUG

Esomeprazole 20mg, Capsules ,orally，BID

esomeprazole 20 mg BID

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

Study Sites (1)

Hangzhou first people's Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Amoxicillin; Esomeprazole

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles

Central Study Contacts

Hongzhang Shen

CONTACT

057156005600; sakshen@126.com

Xiaofeng Zhang

CONTACT

057156005600

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 21, 2022
• Study Start: June 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)