Vonoprazan-Based Triple Therapy in Comparison With Extended Sequential Therapy

NCT05371249 | Unknown Phase 4

• 1 other identifier: FJUH110108
• Study Type: interventional
• Target: 628
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the efficacy of the current standard first-line anti-helicobacter pylori regimen, extended proton pump inhibitor-based sequential therapy, with that of vonoprazan-based triple therapy, through a randomized controlled trial.

Conditions

Helicobacter Pylori

Keywords

Proton Pump Inhibitors

Outcome Measures

Primary Outcomes (1)

• Eradication rate of helicobacter pylori

  Assessed by urea breath test

  Assessed at least 6 weeks after the therapy

Secondary Outcomes (2)

• Adverse effects of the drugs

  After patients completed the therapy (For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy)

• Compliance

  After patients completed the therapy ((For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy)

Study Arms (2)

Vonoprazan-based triple therapy group

EXPERIMENTAL

Including patients receiving vonoprazan-based triple therapy (vonoprazan 20mg + amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days)

Drug: Vonoprazan-based triple therapy

Extended sequential therapy group

ACTIVE COMPARATOR

Including patients receiving extended sequential therapy (lansoprazole 30mg + amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg twice daily for 7 days)

Drug: Extended sequential therapy

Interventions

Vonoprazan-based triple therapy DRUG

vonoprazan 20mg+amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days

Also known as: VAC-7

Vonoprazan-based triple therapy group

Extended sequential therapy DRUG

Lansoprazole 30mg + amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg twice daily for 7 days

Also known as: S-14

Extended sequential therapy group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with H.pylori infection who was over 20 years old and agree to participate in the trial will be recruited.

You may not qualify if:

• Who had received helicobacter pylori eradication before
• Who are known to be allergic to any drug used in this trial
• Pregnant women
• Who are refuse to participate in the trial for any reason

Sponsors & Collaborators

• Fu Jen Catholic University Hospital: lead

Study Sites (1)

Fu Jen Catholic University Hospital

New Taipei City, 243, Taiwan

Location

Related Publications (1)

• Chiu YT, Lee FJ, Kuo CY, Chen YT, Lin YC, Liang KS, Wu CY, Lin RT, Lin JT, Chang CY. Seven-Day Vonoprazan-Based Triple Therapy as First-Line Helicobacter pylori Treatment in Comparison With Extended Sequential Therapy: A Randomized Controlled Trial. Helicobacter. 2024 Jul-Aug;29(4):e13129. doi: 10.1111/hel.13129.

  PMID: 39164808 DERIVED

MeSH Terms

Interventions

ribosomal protein S14

Study Officials

• Yu-tse Chiu, MD

  Fu Jen Catholic University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: May 12, 2022
• Study Start: December 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: February 28, 2024
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD will be available on request for the use of academic research in relevant field after the study is published.
• Access Criteria: The purpose of obtaining the IPD should be for the use of academic research in relevant field.

Locations

TW (1)