Treatment EffectivenessPhase 3NCT06162949
Vonoprazan for Helicobacter Pylori Eradication in Adolescents
A Phase 3 study testing Vonoprazan, Amoxicillin and Clarithromycin in people with Treatment Effectiveness, run by Alexandria University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Treatment Effectiveness
- What is being tested?
- Vonoprazan, Amoxicillin and Clarithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Aug 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vonoprazan-based Triple Therapy vs. Standard Triple Therapy for Helicobacter Pylori Eradication in Adolescents: A Randomized, Double-blinded Controlled Trial
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).
Read the 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.
- Conditions
- Treatment Effectiveness
- Being tested
- Vonoprazan, Amoxicillin, Clarithromycin, Esomeprazole
- Keywords
- Helicobacter pylori, Vonoprazan, Standard triple therapy, Adolescent, Eradication rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
Also called Vonacidan, Tavoniza, Vondalous
an acid suppressor therapy that inhibits the H+, K+-ATPase enzyme system in a potassium-competitive manner.
AmoxicillinDrug
Also called Emox, Ibiamox, Amoxicid
An antibiotic of penicillins antibiotic group
ClarithromycinDrug
Also called Klacid, Klarithro, Klarimix, Infectocure
An antibiotic of macrolide group
EsomeprazoleDrug
Also called Nexium, Neximash, Esomium, Nexicure
An acid suppressor therapy that blocks the proton pump.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Amoxicillin; Drug: Clarithromycin; Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter Pylori eradication rate
Number of patients who will test negative for H. pylori after treatment completion.
Measured: 4 weeks after completion of treatment
Secondary outcomes (1)
The adverse events during therapy
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.
Measured: During the treatment duration, and the end of the 2 weeks treatment protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Jan 2024
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment EffectivenessStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh A. Lashen, Alexandria University
- Investigators
- Sameh A Lashen, MD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162949
- Sponsor's protocol ID
- 0306381
- Status last verified
- Aug 2024
- First submitted
- 30 Nov 2023
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41131746
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vonoprazan-based Triple Therapy vs. Standard Triple Therapy for Helicobacter Pylori Eradication in Adolescents: A Randomized, Double-blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT06162949
- Acronym / sponsor ID
- 0306381
- Conditions
- Treatment Effectiveness
- Keywords
- Helicobacter pylori, Vonoprazan, Standard triple therapy, Adolescent, Eradication rate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan-based triple therapy | Experimental | Drug: Vonoprazan, Drug: Amoxicillin, Drug: ClarithromycinVonoprazan 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" | Active comparator | Drug: Amoxicillin, Drug: Clarithromycin, Drug: EsomeprazoleEsomeprazole 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 |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VonoprazanAlso: Vonacidan, Tavoniza, Vondalousan acid suppressor therapy that inhibits the H+, K+-ATPase enzyme system in a potassium-competitive manner. | Drug | Vonoprazan-based triple therapy |
| AmoxicillinAlso: Emox, Ibiamox, AmoxicidAn antibiotic of penicillins antibiotic group | Drug | Proton pump-based triple therapy "standard triple therapy", Vonoprazan-based triple therapy |
| ClarithromycinAlso: Klacid, Klarithro, Klarimix, InfectocureAn antibiotic of macrolide group | Drug | Proton pump-based triple therapy "standard triple therapy", Vonoprazan-based triple therapy |
| EsomeprazoleAlso: Nexium, Neximash, Esomium, NexicureAn acid suppressor therapy that blocks the proton pump. | Drug | Proton pump-based triple therapy "standard triple therapy" |
Primary outcome
Helicobacter Pylori eradication rate
Time frame: 4 weeks after completion of treatment
Number of patients who will test negative for H. pylori after treatment completion.
1 secondary outcome
The adverse events during therapy
Time frame: During the treatment duration, and the end of the 2 weeks treatment protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Derived from this study: PubMed 41131746Lashen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameh A Lashen, MD principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vonoprazan, Amoxicillin and Clarithromycin in people with Treatment Effectiveness, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter Pylori eradication rate (time frame: 4 weeks after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06162949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.