Helicobacter Pylori InfectionPhase 4NCT07624422
Vonoprazan High-Dose Dual VS Levofloxacin Concomitant
A Phase 4 study testing Vonoprazan and Levofloxacin 500mg in people with Helicobacter Pylori Infection and Peptic Ulcer Disease, run by Damascus Hospital at 1 site in Syria.
Trial summary
This is a randomized controlled trial comparing the efficacy and safety of two vonoprazan-based regimens: high-dose dual therapy (vonoprazan plus a single antibiotic) versus triple therapy (vonoprazan plus two antibiotics) for the treatment of H. pylori infection). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Helicobacter Pylori Infection, Peptic Ulcer Disease, Gastritis
- What is being tested?
- Vonoprazan and Levofloxacin 500mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSyria
- Study dates
- 1 Nov 2026to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 80 years (adjust upper limit as needed)
- Confirmed Helicobacter pylori infection by at least one of the following: positive urea breath test, rapid urease test, histopathology, or stool antigen test
- Treatment-naïve for H. pylori (no prior eradication therapy) - OR - prior treatment failure (specify if rescue therapy)
- Willing and able to provide written informed consent
- Willing to adhere to the 14-day treatment regimen and follow-up visits
- For women of childbearing potential: negative pregnancy test and agreement to use effective contraception during the treatment period
Who cannot join
- History of allergy or hypersensitivity to vonoprazan, amoxicillin, clarithromycin, metronidazole, or any other penicillin/cephalosporin
- Previous H. pylori eradication therapy (if study is for first-line treatment)
- Active gastrointestinal bleeding or perforation
- Severe liver disease (Child-Pugh class B or C) or severe renal impairment (eGFR < 30 mL/min/1.73m²)
- Pregnancy or breastfeeding
- Concurrent use of medications with significant drug-drug interactions (e.g., warfarin, phenytoin, digoxin, atazanavir, rilpivirine)
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- Malignancy or any life-threatening condition with life expectancy < 6 months
- Participation in another interventional trial within 30 days prior to enrollment
- Any condition that, in the investigator's opinion, precludes safe participation or adherence to the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Vonoprazan High-Dose Dual Therapy Compared to Levofloxacin Concomitant Therapy for H. Pylori Eradication: A Randomized Controlled Trial
This is a randomized controlled trial comparing the efficacy and safety of two vonoprazan-based regimens: high-dose dual therapy (vonoprazan plus a single antibiotic) versus triple therapy (vonoprazan plus two antibiotics) for the treatment of H. pylori infection).
Participants will be randomly assigned to receive either regimen for 14 days. The primary outcome is eradication rate , and secondary outcomes include adverse events and treatment adherence.
Read the detailed description
Study Design: This is a prospective, parallel-group, randomized controlled trial.
Setting: multi-center conducted at Damascus hospital and Iben Al-Nfees Hospital
Participants: Adult patients aged [18-70] years with confirmed [condition, e.g., H. pylori infection by urea breath test or histology]. Exclusion criteria include prior [vonoprazan use / antibiotic allergy / pregnancy / significant comorbidity].
Interventions:
Group A (High-Dose Dual Therapy): Vonoprazan [20 mg BID] + [amoxicillin, 1000 mg three times for 14 days.
Group B :levofloxacin concomitant:
levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for 14 days.
Outcomes:
Primary: [Eradication rate / healing rate] assessed at [4-8 weeks post-treatment].
Secondary: Incidence of adverse events (mild, moderate, severe), treatment adherence (pill count or diary), and [other outcomes like symptom improvement or cost-effectiveness].
Sample Size: [N] participants per group to achieve [80-90%] power with alpha = 0.05.
Statistical Analysis: Intention-to-treat and per-protocol analyses. Categorical variables compared using chi-square or Fisher's exact test; continuous variables using t-test or Mann-Whitney U test. A p-value < 0.05 is considered statistically significant.
- Being tested
- Vonoprazan, Levofloxacin 500mg
- Keywords
- Helicobacter Pylori Infection, Vonoprazan
- Medical subject headings
- Peptic Ulcer, Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
Also called Amoxicillin, PPI
Oral medications dispensed at enrollment in blinded (to outcome assessor) packaging. Patients complete a daily medication diary. Adherence assessed by pill count at day 14. No dose adjustments permitted during the 14-day treatment period.
Levofloxacin 500mgDrug
Also called Tinidazole, Amoxicilline, Esomperazole
Oral medications dispensed at enrollment in blinded (to outcome assessor) packaging. Patients complete a daily medication diary. Adherence assessed by pill count at day 14. No dose
| Study group | Role | What they receive |
|---|---|---|
| Vonoprazan High-Dose Dual | Active comparator | Participants receive vonoprazan 20 mg twice daily (BID) plus amoxicillin 1 g three times daily (TID) for 14 days. Vonoprazan is taken before meals. Amoxicillin is taken at evenly spaced intervals (approximately every 8 hours). Receives: Drug: Vonoprazan |
| levofloxacin concomitant | Experimental | (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). Receives: Drug: Levofloxacin 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori Eradication Rate
Proportion of participants with negative H. pylori status confirmed by urea breath test (or stool antigen test) at least 4 weeks after completion of study treatment. Eradication is defined as a negative test result. Both intention-to-treat and per-protocol analyses will be performed.
Measured: two weeks/14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group, randomized, active-controlled, superiority trial. Eligible participants are randomly assigned in a 1:1 ratio to receive either vonoprazan high-dose dual therapy or vonoprazan triple therapy for 14 days.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Damascus Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marouf Alhalabi, Damascus Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624422
- Sponsor's protocol ID
- D202660
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD underlying published results will be shared upon reasonable request to the corresponding author, subject to a signed data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Vonoprazan High-Dose Dual Therapy Compared to Levofloxacin Concomitant Therapy for H. Pylori Eradication: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07624422
- Acronym / sponsor ID
- D202660
- Keywords
- Helicobacter Pylori Infection, Vonoprazan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Damascus HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Jun 2026 (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.
This is a randomized controlled trial comparing the efficacy and safety of two vonoprazan-based regimens: high-dose dual therapy (vonoprazan plus a single antibiotic) versus triple therapy (vonoprazan plus two antibiotics) for the treatment of H. pylori infection).
Participants will be randomly assigned to receive either regimen for 14 days. The primary outcome is eradication rate , and secondary outcomes include adverse events and treatment adherence.
Detailed description
Study Design: This is a prospective, parallel-group, randomized controlled trial.
Setting: multi-center conducted at Damascus hospital and Iben Al-Nfees Hospital
Participants: Adult patients aged [18-70] years with confirmed [condition, e.g., H. pylori infection by urea breath test or histology]. Exclusion criteria include prior [vonoprazan use / antibiotic allergy / pregnancy / significant comorbidity].
Interventions:
Group A (High-Dose Dual Therapy): Vonoprazan [20 mg BID] + [amoxicillin, 1000 mg three times for 14 days.
Group B :levofloxacin concomitant:
levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for 14 days.
Outcomes:
Primary: [Eradication rate / healing rate] assessed at [4-8 weeks post-treatment].
Secondary: Incidence of adverse events (mild, moderate, severe), treatment adherence (pill count or diary), and [other outcomes like symptom improvement or cost-effectiveness].
Sample Size: [N] participants per group to achieve [80-90%] power with alpha = 0.05.
Statistical Analysis: Intention-to-treat and per-protocol analyses. Categorical variables compared using chi-square or Fisher's exact test; continuous variables using t-test or Mann-Whitney U test. A p-value < 0.05 is considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-group, randomized, active-controlled, superiority trial. Eligible participants are randomly assigned in a 1:1 ratio to receive either vonoprazan high-dose dual therapy or vonoprazan triple therapy for 14 days.
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan High-Dose Dual | Active comparator | Drug: VonoprazanParticipants receive vonoprazan 20 mg twice daily (BID) plus amoxicillin 1 g three times daily (TID) for 14 days. Vonoprazan is taken before meals. Amoxicillin is taken at evenly spaced intervals (approximately every 8 hours). |
| levofloxacin concomitant | Experimental | Drug: Levofloxacin 500mg(levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years and ≤ 80 years (adjust upper limit as needed)
- Confirmed Helicobacter pylori infection by at least one of the following: positive urea breath test, rapid urease test, histopathology, or stool antigen test
- Treatment-naïve for H. pylori (no prior eradication therapy) - OR - prior treatment failure (specify if rescue therapy)
- Willing and able to provide written informed consent
- Willing to adhere to the 14-day treatment regimen and follow-up visits
Key exclusion criteria (9 listed)
- History of allergy or hypersensitivity to vonoprazan, amoxicillin, clarithromycin, metronidazole, or any other penicillin/cephalosporin
- Previous H. pylori eradication therapy (if study is for first-line treatment)
- Active gastrointestinal bleeding or perforation
- Severe liver disease (Child-Pugh class B or C) or severe renal impairment (eGFR < 30 mL/min/1.73m²)
- Pregnancy or breastfeeding
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: Amoxicillin, PPIOral medications dispensed at enrollment in blinded (to outcome assessor) packaging. Patients complete a daily medication diary. Adherence assessed by pill count at day 14. No dose adjustments permitted during the 14-day treatment period. | Drug | Vonoprazan High-Dose Dual |
| Levofloxacin 500mgAlso: Tinidazole, Amoxicilline, EsomperazoleOral medications dispensed at enrollment in blinded (to outcome assessor) packaging. Patients complete a daily medication diary. Adherence assessed by pill count at day 14. No dose | Drug | levofloxacin concomitant |
Primary outcome
H. pylori Eradication Rate
Time frame: two weeks/14 days
Proportion of participants with negative H. pylori status confirmed by urea breath test (or stool antigen test) at least 4 weeks after completion of study treatment. Eradication is defined as a negative test result. Both intention-to-treat and per-protocol analyses will be performed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified IPD underlying published results will be shared upon reasonable request to the corresponding author, subject to a signed data access agreement.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vonoprazan and Levofloxacin 500mg in people with Helicobacter Pylori Infection and Peptic Ulcer Disease, run by Damascus Hospital at 1 site in Syria.
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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 3 Jun 2026. 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 Syria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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: two weeks/14 days). 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 3 Jun 2026.