7 Days vs. 14 Days of Vonoprazan-based Triple Therapy for H. Pylori Eradication (VOTE-HP)

February 10, 2025 updated by: Sameh A. Lashen, Alexandria University

7-day Versus 14-day Vonoprazan-based Triple Therapy for Eradication of H. Pylori in Adolescents: A Randomized Controlled Trial

The study aims to test the efficacy of 7 days vs. 14 days of Vonoprazan-triple therapy in the eradication of Helicobacter Pylori infection in adolescents and young children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study details, all eligible participants (or their legal guardians) will give informed written consent to be involved. After a one week screening, eligible participants will be randomized to Vonoprazan plus Amoxicillin plus Clarithromycin triple therapy for either 14 days (group 1), or 7 days (group 2) at a 1:1 ratio. After the end of therapy, H. Pylori eradication will be evaluated after 4 weeks.

Study Type

Interventional

Enrollment (Actual)

326

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Faculty of Medicine, Alexandria University.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participants in the age group (10-18 years), both genders, referred with dyspeptic complaints such as heartburn, dyspepsia, nausea, and epigastric pain who are positive for H. Pylori infection by a standardized diagnostic test.
  2. Pediatric patients with a clinical, laboratory, and endoscopic diagnosis of H.P.-positive gastritis and the other conditions necessary for H.P. eradication, according to the Maastricht V consensus report .

Exclusion Criteria:

  1. allergy to any of the drugs used in the study
  2. previous attempts to eradicate H.P.
  3. receipt of antibiotics, PPIs, bismuth, H2 antagonists or probiotics within 4 weeks of the study.
  4. Children with the diagnosis of any condition that might affect the absorption of drugs such as celiac disease or Crohn's disease.
  5. hepatic impairment or kidney failure.
  6. symptoms suggestive of functional disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 14-days Vonoprazan-based triple therapy
Vonoprazan tablets 20 mg twice daily plus Amoxicillin 50 mg/kg/day capsules or suspension [maximum daily dose 2 g] plus Clarithromycin 20 mg/kg/day tablets or suspension [maximum daily dose 1 g]. The triple combination will be given for 14 days .
Drug: Vonoprazan
Participants will receive Vonoprazan 20 mg tablets twice daily before meals.
Other Names:
  • Vonacidan
  • Tavoniza
  • Vondalous
  • Vonaspire
  • Vonseca
Drug: Amoxicillin
Participants will receive Amoxicillin 50 mg/kg/day capsules or suspension [maximum daily dose: 2 g].
Other Names:
  • Emox
  • Ibiamox
  • Amoxicid
Drug: Clarithromycin
Participants will receive Clarithromycin 20 mg/kg/day tablets or suspension [maximum daily dose: 1 g].
Other Names:
  • Klacid
  • Klarithro
  • Klarimix
  • Infectocure
Experimental: 7-days Vonoprazan-based triple therapy
Vonoprazan tablets 20 mg twice daily plus Amoxicillin 50 mg/kg/day capsules or suspension [maximum daily dose 2 g] plus Clarithromycin 20 mg/kg/day tablets or suspension [maximum daily dose 1 g]. The triple combination will be given for 7 days.
Drug: Vonoprazan
Participants will receive Vonoprazan 20 mg tablets twice daily before meals.
Other Names:
  • Vonacidan
  • Tavoniza
  • Vondalous
  • Vonaspire
  • Vonseca
Drug: Amoxicillin
Participants will receive Amoxicillin 50 mg/kg/day capsules or suspension [maximum daily dose: 2 g].
Other Names:
  • Emox
  • Ibiamox
  • Amoxicid
Drug: Clarithromycin
Participants will receive Clarithromycin 20 mg/kg/day tablets or suspension [maximum daily dose: 1 g].
Other Names:
  • Klacid
  • Klarithro
  • Klarimix
  • Infectocure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
H. Pylori eradication rate
Time Frame: 4 weeks after completion of treatment
Number of participants who will achieve a negative H. pylori antigen detection test after the end of therapy.
4 weeks after completion of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events during treatment.
Time Frame: From first dose of treatment until 7 or 14 days of treatment regimen assigned.
Type and frequency of treatment-related adverse effects in both arms
From first dose of treatment until 7 or 14 days of treatment regimen assigned.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Sameh A Lashen, MD, Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2024

Primary Completion (Actual)

November 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0306630

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Clinico-laboratory data can be shared, but participant-specific identity data cannot be shared to maintain participant confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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