7 Days vs. 14 Days of Vonoprazan-based Triple Therapy for H. Pylori Eradication

NCT06576882 | Completed Phase 3

• 1 other identifier: 0306630
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Helicobacter Pylori Infection; Gastritis; Vonoprazan; Adolescents

Keywords

Helicobacter pylori; Vonoprazan; Triple therapy; Adolescent; Eradication rate; Children

Outcome Measures

Primary Outcomes (1)

• H. Pylori eradication rate

  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 Outcomes (1)

• Adverse events during treatment.

  From first dose of treatment until 7 or 14 days of treatment regimen assigned.

Study Arms (2)

14-days Vonoprazan-based triple therapy

ACTIVE COMPARATOR

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; Drug: Amoxicillin; Drug: Clarithromycin

7-days Vonoprazan-based triple therapy

EXPERIMENTAL

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; Drug: Amoxicillin; Drug: Clarithromycin

Interventions

Vonoprazan DRUG

Participants will receive Vonoprazan 20 mg tablets twice daily before meals.

Also known as: Vonacidan, Tavoniza, Vondalous, Vonaspire, Vonseca

14-days Vonoprazan-based triple therapy; 7-days Vonoprazan-based triple therapy

Amoxicillin DRUG

Participants will receive Amoxicillin 50 mg/kg/day capsules or suspension \[maximum daily dose: 2 g\].

Also known as: Emox, Ibiamox, Amoxicid

14-days Vonoprazan-based triple therapy; 7-days Vonoprazan-based triple therapy

Clarithromycin DRUG

Participants will receive Clarithromycin 20 mg/kg/day tablets or suspension \[maximum daily dose: 1 g\].

Also known as: Klacid, Klarithro, Klarimix, Infectocure

14-days Vonoprazan-based triple therapy; 7-days Vonoprazan-based triple therapy

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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 .

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine, Alexandria University.

Alexandria, Egypt

Location

MeSH Terms

Conditions

Gastritis

Interventions

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

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

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; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Sameh A Lashen, MD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 1:1 assignment.

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 29, 2024
• Study Start: June 30, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 11, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)