Helicobacter Pylori InfectionPhase 4NCT06959368
Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication
A Phase 4 study testing Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg in people with Helicobacter Pylori Infection, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Helicobacter pylori (H Pylori) infection is associated with functional dyspepsia, peptic ulcer disease, atrophy and gastric cancer. The bacterium has been classified as grade I carcinogen by the WHO in 1994(1). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- 1 siteIndia
- Study dates
- 25 Mar 2025to 25 Mar 2026
- 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
- Adult (18 years - 80 years)
- Patient visiting clinic with dyspepsia, GERD, or non-bleeding peptic ulcer
- 13C-urea breath test (UBT) positive/ Rapid urease test positive (RUT) on endoscopic biopsy
- Off PPIs for 2 weeks
Who cannot join
- Penicillin allergy
- Recent use of antibiotics in the past 1 month
- Previous H. pylori therapy
- Intestinal metaplasia, gastric cancer, bleeding peptic ulcer
- Patient who is unable to understand study protocol or not consenting
- Pregnancy, lactation
Show all 9Show fewer
- Patient on anticoagulation, NSAIDs
- Patient using drugs with interactions with vonoprazan, amoxicillin, clarithromycin or PPIs
- Cirrhosis, Chronic kidney disease, chronic lung disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
AIG hospitals
Hyderabad, Telangana, 500082
AIG hospitals, 040 4244 4222, info@aighospitals.com
Koduri Krithi Krishna, MBBS, MD, DNB
About this study
Official title: A Randomised Controlled Trial Comparing Vonoprazan Triple Therapy (Vonoprazan, Amoxicillin, Clarithromycin), and Standard Triple Therapy (Esomeprazole, Amoxicillin, Clarithromycin) for Helicobacter Pylori Eradication in Indian Population. VECTOR Trial - Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication
Helicobacter pylori (H Pylori) infection is associated with functional dyspepsia, peptic ulcer disease, atrophy and gastric cancer. The bacterium has been classified as grade I carcinogen by the WHO in 1994(1). Based on the clinical and microbiological data it is now well known to be the strongest risk factor for developing intestinal type and diffuse type of adenocarcinoma(2-4). While testing and treating asymptomatic persons is a grey area, it is now recommended to rule out H. pylori in un-investigated dyspepsia patients (5-7), and if detected, it must be treated. However, worldwide and especially in the Asian countries, we face a widespread problem of antibiotic resistance(8,9). Regimens are typically selected based on the varying regional clarithromycin resistance(6,9). There is a need for an efficient and reliable empirical therapy that can be universal, has maximal eradication rates irrespective of resistance patterns, has good compliance and minimal adverse events without the emergence of superbugs. We also need a reliable rescue therapy for H. pylori eradication failure.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mgDrug
Participants will receive the respective drug regimens twice daily. The Vonoprazan triple therapy arm will administer Vonoprazan 20 mg, Amoxicillin 1 g, and Clarithromycin 500 mg twice daily. The Standard triple therapy arm will administer Esomeprazole 40 mg, Amoxicillin 1 g, and Clarithromycin 500 mg twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Vonoprazan triple therapy | Active comparator | • Vonoprazan Triple Therapy: Vonoprazan 20 mg, Amoxicillin 1 g, Clarithromycin 500 mg (all twice daily). Receives: Drug: Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg |
| Standard triple therapy | Active comparator | • Standard Triple Therapy: Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg (all twice daily). Receives: Drug: Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
A randomised controlled trial comparing Vonoprazan triple therapy (Vonoprazan, Amoxicillin, Clarithromycin), and standard triple therapy (Esomeprazole, Amoxicillin, Clarithromycin) for Helicobacter pylori eradication in Indian population. VECTOR trial
The primary outcome measurement is to assess the eradication of H. pylori i.e. negative UBT or stool antigen test 4 weeks after treatment
Measured: 1 year
Secondary outcomes (1)
Assessment of adverse events and eradication rates in antibiotic-resistant strains.
Assessment of adverse events and eradication rates in antibiotic-resistant strains.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start25 Mar 2025
- Primary completion25 Mar 2026 (estimated)
- Study completion25 Mar 2026 (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.
- More trials run by Asian Institute of Gastroenterology, IndiaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959368
- Sponsor's protocol ID
- VECTOR-01
- Status last verified
- Feb 2025
- First submitted
- 28 Apr 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Comparing Vonoprazan Triple Therapy (Vonoprazan, Amoxicillin, Clarithromycin), and Standard Triple Therapy (Esomeprazole, Amoxicillin, Clarithromycin) for Helicobacter Pylori Eradication in Indian Population. VECTOR Trial - Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication
- ClinicalTrials.gov ID
- NCT06959368
- Acronym / sponsor ID
- VECTOR-01
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 25 Mar 2026 (estimated)
- Study completion
- 25 Mar 2026 (estimated)
- First posted
- 6 May 2025 (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.
Helicobacter pylori (H Pylori) infection is associated with functional dyspepsia, peptic ulcer disease, atrophy and gastric cancer. The bacterium has been classified as grade I carcinogen by the WHO in 1994(1). Based on the clinical and microbiological data it is now well known to be the strongest risk factor for developing intestinal type and diffuse type of adenocarcinoma(2-4). While testing and treating asymptomatic persons is a grey area, it is now recommended to rule out H. pylori in un-investigated dyspepsia patients (5-7), and if detected, it must be treated. However, worldwide and especially in the Asian countries, we face a widespread problem of antibiotic resistance(8,9). Regimens are typically selected based on the varying regional clarithromycin resistance(6,9). There is a need for an efficient and reliable empirical therapy that can be universal, has maximal eradication rates irrespective of resistance patterns, has good compliance and minimal adverse events without the emergence of superbugs. We also need a reliable rescue therapy for H. pylori eradication failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan triple therapy | Active comparator | Drug: Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg• Vonoprazan Triple Therapy: Vonoprazan 20 mg, Amoxicillin 1 g, Clarithromycin 500 mg (all twice daily). |
| Standard triple therapy | Active comparator | Drug: Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg• Standard Triple Therapy: Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg (all twice daily). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (18 years - 80 years)
- Patient visiting clinic with dyspepsia, GERD, or non-bleeding peptic ulcer
- 13C-urea breath test (UBT) positive/ Rapid urease test positive (RUT) on endoscopic biopsy
- Off PPIs for 2 weeks
Key exclusion criteria (9 listed)
- Penicillin allergy
- Recent use of antibiotics in the past 1 month
- Previous H. pylori therapy
- Intestinal metaplasia, gastric cancer, bleeding peptic ulcer
- Patient who is unable to understand study protocol or not consenting
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 |
|---|---|---|
| Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mgParticipants will receive the respective drug regimens twice daily. The Vonoprazan triple therapy arm will administer Vonoprazan 20 mg, Amoxicillin 1 g, and Clarithromycin 500 mg twice daily. The Standard triple therapy arm will administer Esomeprazole 40 mg, Amoxicillin 1 g, and Clarithromycin 500 mg twice daily. | Drug | Standard triple therapy, Vonoprazan triple therapy |
Primary outcome
A randomised controlled trial comparing Vonoprazan triple therapy (Vonoprazan, Amoxicillin, Clarithromycin), and standard triple therapy (Esomeprazole, Amoxicillin, Clarithromycin) for Helicobacter pylori eradication in Indian population. VECTOR trial
Time frame: 1 year
The primary outcome measurement is to assess the eradication of H. pylori i.e. negative UBT or stool antigen test 4 weeks after treatment
1 secondary outcome
Assessment of adverse events and eradication rates in antibiotic-resistant strains.
Time frame: 1 year
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 11 Jun 2025.
- 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.
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 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg in people with Helicobacter Pylori Infection, run by Asian Institute of Gastroenterology, India at 1 site in India.
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 4 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: looking for participants now, as of the sponsor's last update on 11 Jun 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 India. 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?
Contact Krithi Krishna Koduri Doctor (+91 9870083545, drkrithivk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A randomised controlled trial comparing Vonoprazan triple therapy (Vonoprazan, Amoxicillin, Clarithromycin), and standard triple therapy (Esomeprazole, Amoxicillin, Clarithromycin) for Helicobacter pylori eradication in Indian population. VECTOR trial (time frame: 1 year). 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 Jun 2025.