Vonoprazan for Helicobacter Pylori Eradication in Adolescents
NCT ID: NCT06162949
Last Updated: 2024-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
242 participants
INTERVENTIONAL
2024-01-01
2024-08-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Vonoprazan
an acid suppressor therapy that inhibits the H+, K+-ATPase enzyme system in a potassium-competitive manner.
Amoxicillin
An antibiotic of penicillins antibiotic group
Clarithromycin
An antibiotic of macrolide group
Proton pump-based triple therapy "standard triple therapy"
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
Amoxicillin
An antibiotic of penicillins antibiotic group
Clarithromycin
An antibiotic of macrolide group
Esomeprazole
An acid suppressor therapy that blocks the proton pump.
Interventions
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Vonoprazan
an acid suppressor therapy that inhibits the H+, K+-ATPase enzyme system in a potassium-competitive manner.
Amoxicillin
An antibiotic of penicillins antibiotic group
Clarithromycin
An antibiotic of macrolide group
Esomeprazole
An acid suppressor therapy that blocks the proton pump.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
10 Years
18 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Responsible Party
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Sameh A. Lashen
Assistant Professor
Principal Investigators
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Sameh A Lashen, MD
Role: PRINCIPAL_INVESTIGATOR
Alexandria University
Locations
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Faculty of Medicine
Alexandria, , Egypt
Countries
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References
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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.
Other Identifiers
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0306381
Identifier Type: -
Identifier Source: org_study_id
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