Helicobacter Pylori InfectionPhase 3NCT05728424
One vs Two Weeks Treatment for H.Pylori Eradication A RANDOMIZED NON-INFERIORITY PLACEBO CONTROLLED TRIAL
A Phase 3 study testing Vonoprazan, Amoxicillin, Levofloxacin in people with Helicobacter Pylori Infection, run by Aga Khan University at 1 site in Pakistan.
Trial summary
1. To assess the efficacy of the duration of Vonoprazan based triple regimen (one versus two weeks), in the eradication of H-pylori among patients attending gastroenterology clinics of Karachi, Pakistan. 2. To assess the improvement in the quality of life of patients receiving Vonoprazan as part of the triple regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Vonoprazan, Amoxicillin, Levofloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Sep 2022to 1 May 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- H pylori infection confirmed by any of the 3 tests C-urea breath test (UBT), , rapid urease test, and stool H pylori antigen.
Who cannot join
- acute gastrointestinal disease (e.g., acute diarrhea)
- chronic gastrointestinal disease (e.g., inflammatory bowel disease, celiac disease)
- known renal and/or liver failure
- no known malignancy
- varices bleeding
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University Hospital
Karachi, Sindh
Muhammad qasim chaudhry, mobs, 923009506815, Chaudhry.qasim@alumni.aku.edu
About this study
Official title: ONE WEEK VS. TWO WEEKS VONOPRAZAN CONTAINING TRIPLE REGIMEN FOR ERADICATION OF HELICOBACTER PYLORI:
- To assess the efficacy of the duration of Vonoprazan based triple regimen (one versus two weeks), in the eradication of H-pylori among patients attending gastroenterology clinics of Karachi, Pakistan.
- To assess the improvement in the quality of life of patients receiving Vonoprazan as part of the triple regimen.
Read the detailed description
Introduction: The overall aim of the study is to assess the efficacy of one week of Vonoprazan compared to two weeks of Vonoprazan in eradicating H-Pylori in patients with dyspeptic symptoms.
- pylori is a pathogenic Gram-negative spiral bacillus that survives in the acid environment of the stomach. It is a leading cause of chronic gastritis, peptic ulcers, non-ulcer dyspepsia, gastric adenocarcinoma and mucosa-associated lymphoid tissue (MALT) lymphoma. It is estimated that up to 50% of the total world population are infected with H. pylori. The prevalence of H. Pylori infection is currently rising in the developing world. Modified one-week triple therapy (two antibiotics for a week and a potassium-competitive acid blocker for 4-8 weeks) represents the most advanced prescribed regimen for H. pylori infection. With current and widely used therapeutic regimens, (such as two antibiotics and a proton pump inhibitor) there is a significant failure rate for the eradication of microorganism. Therefore, interventions that can improve H-pylori eradication along with improving patient's quality of life are highly important.
Vonoprazan is a potassium-competitive acid blocker, which inhibits the H+/K+ pump in the stomach. Unlike proton pump inhibitors, Vonoprazan inhibits the pump in a competitive and reversible manner. Hence, it is expected to be at least as effective as PPIs in the elimination of Helicobacter Pylori. Assessing the duration of Vonoprazan based triple therapy is of great concern.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Vonoprazan, Amoxicillin, Levofloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonoprazan, Amoxicillin, LevofloxacinDrug
No additional information
| Study group | Role | What they receive |
|---|---|---|
| 2 weeks vonoprazan containing triple regimen | Active comparator | For two weeks:
Vonaprazan: 20 mg twice daily Amoxicillin: 1gm twice daily Levofloxacin: 500 mg once daily Receives: Drug: Vonoprazan, Amoxicillin, Levofloxacin |
| 1 week vonoprazan containing triple regimen | Placebo comparator | For One week:
Vonaprazan: 20 mg twice daily Amoxicillin: 1gm twice daily Levofloxacin: 500 mg once daily
For the second week:
Placebo Receives: Drug: Vonoprazan, Amoxicillin, Levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of triple therapy in eradication of H.pylori (based on duration)
- To assess the efficacy of the duration of Vonoprazan based triple regimen (one versus two weeks), in the eradication of H-pylori among patients attending gastroenterology clinics of Karachi, Pakistan.
The eradication of H.pylori will be tested using the Urea breath test 6 weeks post treatment.
Measured: 6 months
Secondary outcomes (1)
Quality of life assessment using QoLRAD (quality of life in reflux and dyspepsia)
- To assess the improvement in the quality of life of patients receiving Vonoprazan as part of the triple regimen.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start20 Sep 2022
- Primary completion1 Apr 2023 (estimated)
- Study completion1 May 2023 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Searle Pharmaceuticals
- Responsible party
- Principal investigator, SHAHAB ABID, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728424
- Sponsor's protocol ID
- 2022-7002-21047
- Status last verified
- Feb 2023
- First submitted
- 9 Jan 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ONE WEEK VS. TWO WEEKS VONOPRAZAN CONTAINING TRIPLE REGIMEN FOR ERADICATION OF HELICOBACTER PYLORI:
- ClinicalTrials.gov ID
- NCT05728424
- Acronym / sponsor ID
- 2022-7002-21047
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Searle Pharmaceuticals
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 15 Feb 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.
- To assess the efficacy of the duration of Vonoprazan based triple regimen (one versus two weeks), in the eradication of H-pylori among patients attending gastroenterology clinics of Karachi, Pakistan.
- To assess the improvement in the quality of life of patients receiving Vonoprazan as part of the triple regimen.
Detailed description
Introduction: The overall aim of the study is to assess the efficacy of one week of Vonoprazan compared to two weeks of Vonoprazan in eradicating H-Pylori in patients with dyspeptic symptoms.
- pylori is a pathogenic Gram-negative spiral bacillus that survives in the acid environment of the stomach. It is a leading cause of chronic gastritis, peptic ulcers, non-ulcer dyspepsia, gastric adenocarcinoma and mucosa-associated lymphoid tissue (MALT) lymphoma. It is estimated that up to 50% of the total world population are infected with H. pylori. The prevalence of H. Pylori infection is currently rising in the developing world. Modified one-week triple therapy (two antibiotics for a week and a potassium-competitive acid blocker for 4-8 weeks) represents the most advanced prescribed regimen for H. pylori infection. With current and widely used therapeutic regimens, (such as two antibiotics and a proton pump inhibitor) there is a significant failure rate for the eradication of microorganism. Therefore, interventions that can improve H-pylori eradication along with improving patient's quality of life are highly important.
Vonoprazan is a potassium-competitive acid blocker, which inhibits the H+/K+ pump in the stomach. Unlike proton pump inhibitors, Vonoprazan inhibits the pump in a competitive and reversible manner. Hence, it is expected to be at least as effective as PPIs in the elimination of Helicobacter Pylori. Assessing the duration of Vonoprazan based triple therapy is of great concern.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 weeks vonoprazan containing triple regimen | Active comparator | Drug: Vonoprazan, Amoxicillin, LevofloxacinFor two weeks: Vonaprazan: 20 mg twice daily Amoxicillin: 1gm twice daily Levofloxacin: 500 mg once daily |
| 1 week vonoprazan containing triple regimen | Placebo comparator | Drug: Vonoprazan, Amoxicillin, LevofloxacinFor One week: Vonaprazan: 20 mg twice daily Amoxicillin: 1gm twice daily Levofloxacin: 500 mg once daily For the second week: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- H pylori infection confirmed by any of the 3 tests C-urea breath test (UBT), , rapid urease test, and stool H pylori antigen.
Key exclusion criteria (5 listed)
- acute gastrointestinal disease (e.g., acute diarrhea)
- chronic gastrointestinal disease (e.g., inflammatory bowel disease, celiac disease)
- known renal and/or liver failure
- no known malignancy
- varices bleeding
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, Amoxicillin, LevofloxacinNo additional information | Drug | 1 week vonoprazan containing triple regimen, 2 weeks vonoprazan containing triple regimen |
Primary outcome
Efficacy of triple therapy in eradication of H.pylori (based on duration)
Time frame: 6 months
a) To assess the efficacy of the duration of Vonoprazan based triple regimen (one versus two weeks), in the eradication of H-pylori among patients attending gastroenterology clinics of Karachi, Pakistan. The eradication of H.pylori will be tested using the Urea breath test 6 weeks post treatment.
1 secondary outcome
Quality of life assessment using QoLRAD (quality of life in reflux and dyspepsia)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
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, Levofloxacin in people with Helicobacter Pylori Infection, run by Aga Khan University at 1 site in Pakistan.
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 5 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: status not confirmed, as of the sponsor's last update on 15 Feb 2023. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shahab abid, MBBS, PhD (923333965940, shahab.abid@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of triple therapy in eradication of H.pylori (based on duration) (time frame: 6 months). 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 15 Feb 2023.