Vonoprazan for Helicobacter Pylori Eradication in Adolescents

NCT06162949 | Completed Phase 3

• 1 other identifier: 0306381
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

The trial tends to evaluate the efficacy of vonoprazan-based triple therapy in eradicating H. Pylori infection in adolescent patients in Egypt, in comparison to standard treatment regimens to determine if it offers superior eradication rates (VONTAPE trial).

Conditions

Treatment Effectiveness

Keywords

Helicobacter pylori; Vonoprazan; Standard triple therapy; Adolescent; Eradication rate

Outcome Measures

Primary Outcomes (1)

• Helicobacter Pylori eradication rate

  Number of patients who will test negative for H. pylori after treatment completion.

  4 weeks after completion of treatment

Secondary Outcomes (1)

• The adverse events during therapy

  During the treatment duration, and the end of the 2 weeks treatment protocol

Study Arms (2)

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 14 days

Drug: Vonoprazan; Drug: Amoxicillin; Drug: Clarithromycin

Proton pump-based triple therapy "standard triple therapy"

ACTIVE COMPARATOR

Esomeprazole tablets \[20 mg/day if \< 30 kg and 40 mg/daily if ≥ 30 kg\] on two divided daily doses 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: Amoxicillin; Drug: Clarithromycin; Drug: Esomeprazole

Interventions

Vonoprazan DRUG

an acid suppressor therapy that inhibits the H+, K+-ATPase enzyme system in a potassium-competitive manner.

Also known as: Vonacidan, Tavoniza, Vondalous

Vonoprazan-based triple therapy

Amoxicillin DRUG

An antibiotic of penicillins antibiotic group

Also known as: Emox, Ibiamox, Amoxicid

Proton pump-based triple therapy "standard triple therapy"; Vonoprazan-based triple therapy

Clarithromycin DRUG

An antibiotic of macrolide group

Also known as: Klacid, Klarithro, Klarimix, Infectocure

Proton pump-based triple therapy "standard triple therapy"; Vonoprazan-based triple therapy

Esomeprazole DRUG

An acid suppressor therapy that blocks the proton pump.

Also known as: Nexium, Neximash, Esomium, Nexicure

Proton pump-based triple therapy "standard 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:

• Children in the age group (10-18 years), both genders, referred with dyspeptic complaints such as heartburn, dyspepsia, nausea, and epigastric pain.
• Who is 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.
• Use of antibiotics, acid-suppression, bismuth, or probiotics 4 weeks before enrollment.
• Children with conditions that affect medication absorption e.g. celiac or Crohn's disease.
• Liver or kidney failure.
• symptoms suggestive of functional disorders.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine

Alexandria, 21521, Egypt

Location

Related Publications (1)

• Lashen SA, Shamseyea MM, Metwally RH, Abou-Farrag G, Elkaragy ES. Vonoprazan-Based Triple Therapy Versus Esomeprazole-Based Triple Therapy for H. pylori Eradication in Adolescents (VONTAPE): A Randomized, Double-Blind Controlled Trial. Helicobacter. 2025 Sep-Oct;30(5):e70083. doi: 10.1111/hel.70083.

  PMID: 41131746 DERIVED

MeSH Terms

Interventions

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

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; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles

Study Officials

• Sameh A Lashen, MD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: January 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)