High-dose Dual Therapy with Different Administration Frequencies

NCT05901051 | Completed Phase 4 DMC

• 1 other identifier: rjyy20210815
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single center, randomized controlled clinical study. The enrolled patients are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea breath test. According to the declaration of Helsinki, 327 patients will be included in this study. After obtaining the written informed consent of the patients, HP culture and drug sensitivity test will be conducted on all the selected patients with the success rate, adverse reactions, compliance, antibiotic resistance of HP and its impact on HP eradication.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Dual Therapy

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication rate

  Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-rea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).

  Six weeks after completion of therapy

Secondary Outcomes (2)

• Rate of adverse events

  Within 7 days after completion of therapy

• Compliance rate

  Within 7 days after completion of therapy

Study Arms (3)

dual therapy A

EXPERIMENTAL

Vonoprazan 20mg bid ac and amoxicillin 0.75g qid pc

Drug: vonoprazan; Drug: Amoxicillin

dual therapy B

EXPERIMENTAL

Vonoprazan 20mg bid ac and amoxicillin 1g tid pc

Drug: vonoprazan; Drug: Amoxicillin

dual therapy C

EXPERIMENTAL

Vonoprazan 20mg bid ac and amoxicillin 1g tid ac

Drug: vonoprazan; Drug: Amoxicillin

Interventions

vonoprazan DRUG

Potassium competitive acid blocker

dual therapy A; dual therapy B; dual therapy C

Amoxicillin DRUG

Antibiotics for H. pylori eradication

dual therapy A; dual therapy B; dual therapy C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability and willingness to participate in the study and to sign and give informed consent
• Confirmed H. pylori infection

You may not qualify if:

• Pregnant and lactating women;
• History of gastrointestinal malignancies;
• History of previous subtotal gastrectomy;
• Serious dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases; Such as grade IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson disease, etc;
• History of hematological diseases
• People who are allergic to drugs;
• The guardian or patient refused to join the group;
• Alcohol and / or drug abuse (addiction or dependence) or poor compliance judged by doctors;
• No legal capacity or poor self-knowledge
• administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (1)

• Qiu S, Huang Y, Chen J, Guo Y, Li M, Ding Z, Liang X, Lu H. Vonoprazan-Amoxicillin Dual Therapy With Different Amoxicillin Administration Regimens for Helicobacter pylori Treatment: A Randomized Controlled Trial. Helicobacter. 2024 Jul-Aug;29(4):e13118. doi: 10.1111/hel.13118.

  PMID: 39087868 DERIVED

MeSH Terms

Interventions

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

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

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: Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: June 13, 2023
• Study Start: March 30, 2021
• Primary Completion: September 10, 2023
• Study Completion: September 30, 2023
• Last Updated: December 30, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)