Vonoprazan for Helicobacter Pylori Eradication in Adolescents

Phase 3

Completed

• Conditions: Treatment Effectiveness
• Interventions: Drug: Vonoprazan; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Esomeprazole

• Registration Number: NCT06162949
• Lead Sponsor: Alexandria University

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).

Detailed Description

The VONTAPE trial will compare two treatment regimens for Helicobacter pylori eradication among adolescent patients presented to the gastroenterology department in an Egyptian institute. the eligible subjects will be randomly assigned to one of the two protocols (vonoprazan based vs. proton pump inhibitor-based triple therapy) for two weeks. then the eradication rates will be compared between the two study groups to see if there is a difference in efficacy.

The currently available eradication regimens in our country show a low to intermediate eradication rate (50-75%). At the same time, H. pylori infection is prevalent.

Recently, the FDA approved vonoprazan-based regimens for adult H. pylori infection with high eradication rates even in the settings of clarithromycin antibiotic resistance.

In the VOTSAPE trial, we will test this efficacy in the \< 18 years adolescents.

Study Timeline

• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-08
• Study Start: 2024-01-01
• Status Verified: 2024-08
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

1. Children in the age group (10-18 years), both genders, referred with dyspeptic complaints such as heartburn, dyspepsia, nausea, and epigastric pain.
2. Who is positive for H. Pylori infection by a standardized diagnostic test.
3. 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. Use of antibiotics, acid-suppression, bismuth, or probiotics 4 weeks before enrollment.
4. Children with conditions that affect medication absorption e.g. celiac or Crohn's disease.
5. Liver or kidney failure.
6. symptoms suggestive of functional disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vonoprazan-based triple therapy	Clarithromycin	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
Vonoprazan-based triple therapy	Vonoprazan	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
Vonoprazan-based triple therapy	Amoxicillin	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
Proton pump-based triple therapy "standard triple therapy"	Amoxicillin	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
Proton pump-based triple therapy "standard triple therapy"	Esomeprazole	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
Proton pump-based triple therapy "standard triple therapy"	Clarithromycin	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

Primary Outcome Measures

Name	Time	Method
Helicobacter Pylori eradication rate	4 weeks after completion of treatment	Number of patients who will test negative for H. pylori after treatment completion.

Secondary Outcome Measures

Name	Time	Method
The adverse events during therapy	During the treatment duration, and the end of the 2 weeks treatment protocol	Treatment-related adverse effects (TRAEs) such as abdominal discomfort, diarrhea, vomiting, nausea, flatulence, taste disturbance, or loss of appetite, the need for discontinuation of the H. pylori therapy; and/or headache.

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Alexandria, Egypt