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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
326

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexandria University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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