Helicobacter Pylori InfectionPhase 3VOTE-HPNCT06576882
7 Days vs. 14 Days of Vonoprazan-based Triple Therapy for H. Pylori Eradication
A Phase 3 study testing Vonoprazan, Amoxicillin and Clarithromycin in people with Helicobacter Pylori Infection and Gastritis, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Helicobacter Pylori Infection, Gastritis, Vonoprazan
- 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
- 326 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2024to 1 Dec 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
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 7-day Versus 14-day Vonoprazan-based Triple Therapy for Eradication of H. Pylori in Adolescents: A Randomized Controlled Trial
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.
Read the detailed description
After being informed about the study details, all eligible participants (or their legal guardians) will give informed written consent to be involved. After a one week screening, eligible participants will be randomized to Vonoprazan plus Amoxicillin plus Clarithromycin triple therapy for either 14 days (group 1), or 7 days (group 2) at a 1:1 ratio. After the end of therapy, H. Pylori eradication will be evaluated after 4 weeks.
- Conditions
- Helicobacter Pylori Infection, Gastritis, Vonoprazan, Adolescents
- Being tested
- Vonoprazan, Amoxicillin, Clarithromycin
- Keywords
- Helicobacter pylori, Vonoprazan, Triple therapy, Adolescent, Eradication rate, Children
- Medical subject headings
- Gastritis
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, Vonaspire
Participants will receive Vonoprazan 20 mg tablets twice daily before meals.
AmoxicillinDrug
Also called Emox, Ibiamox, Amoxicid
Participants will receive Amoxicillin 50 mg/kg/day capsules or suspension [maximum daily dose: 2 g].
ClarithromycinDrug
Also called Klacid, Klarithro, Klarimix, Infectocure
Participants will receive Clarithromycin 20 mg/kg/day tablets or suspension [maximum daily dose: 1 g].
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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. Receives: Drug: Vonoprazan; Drug: Amoxicillin; Drug: Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. Pylori eradication rate
Number of participants who will achieve a negative H. pylori antigen detection test after the end of therapy.
Measured: 4 weeks after completion of treatment
Secondary outcomes (1)
Adverse events during treatment.
Type and frequency of treatment-related adverse effects in both arms
Measured: From first dose of treatment until 7 or 14 days of treatment regimen assigned.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start30 Jun 2024
- Primary completion1 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies 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
- Model description
- 1:1 assignment.
- Masking
- None (open label)
- Enrolment
- 326 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
- NCT06576882
- Sponsor's protocol ID
- 0306630
- Acronym
- VOTE-HP
- Status last verified
- Apr 2024
- First submitted
- 26 Aug 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Clinico-laboratory data can be shared, but participant-specific identity data cannot be shared to maintain participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 7-day Versus 14-day Vonoprazan-based Triple Therapy for Eradication of H. Pylori in Adolescents: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06576882
- Acronym / sponsor ID
- VOTE-HP / 0306630
- Conditions
- Helicobacter Pylori Infection, Gastritis, Vonoprazan, Adolescents
- Keywords
- Helicobacter pylori, Vonoprazan, Triple therapy, Adolescent, Eradication rate, Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 29 Aug 2024 (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 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.
Detailed description
After being informed about the study details, all eligible participants (or their legal guardians) will give informed written consent to be involved. After a one week screening, eligible participants will be randomized to Vonoprazan plus Amoxicillin plus Clarithromycin triple therapy for either 14 days (group 1), or 7 days (group 2) at a 1:1 ratio. After the end of therapy, H. Pylori eradication will be evaluated after 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 assignment.
| Arm | Type | Receives |
|---|---|---|
| 14-days Vonoprazan-based triple therapy | Active comparator | 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 . |
| 7-days 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 7 days. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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 .
Key exclusion criteria (6 listed)
- 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.
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, Vondalous, VonaspireParticipants will receive Vonoprazan 20 mg tablets twice daily before meals. | Drug | 14-days Vonoprazan-based triple therapy, 7-days Vonoprazan-based triple therapy |
| AmoxicillinAlso: Emox, Ibiamox, AmoxicidParticipants will receive Amoxicillin 50 mg/kg/day capsules or suspension [maximum daily dose: 2 g]. | Drug | 14-days Vonoprazan-based triple therapy, 7-days Vonoprazan-based triple therapy |
| ClarithromycinAlso: Klacid, Klarithro, Klarimix, InfectocureParticipants will receive Clarithromycin 20 mg/kg/day tablets or suspension [maximum daily dose: 1 g]. | Drug | 14-days Vonoprazan-based triple therapy, 7-days Vonoprazan-based triple therapy |
Primary outcome
H. Pylori eradication rate
Time frame: 4 weeks after completion of treatment
Number of participants who will achieve a negative H. pylori antigen detection test after the end of therapy.
1 secondary outcome
Adverse events during treatment.
Time frame: From first dose of treatment until 7 or 14 days of treatment regimen assigned.
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 11 Feb 2025.
- Individual participant dataSharing planned: No. Clinico-laboratory data can be shared, but participant-specific identity data cannot be shared to maintain participant confidentiality.
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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 Helicobacter Pylori Infection and Gastritis, 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 2 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 11 Feb 2025. 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?
H. 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?
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 11 Feb 2025.