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Compares treatment options for Helicobacter Pylori Infection
Official title Vonoprazan-based Versus Esomeprazole-based Triple Therapy for Helicobacter Pylori Eradication
ClinicalTrials.gov ID: NCT07537634
What this study is testing
What is vonoprazan-based triple therapy (VAL regimen)?
vonoprazan-based triple therapy (VAL regimen) is an investigational medicine, given as an once-daily, being studied as a potential treatment for helicobacter pylori infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to compare the efficacy and safety of vonoprazan-based levofloxacin-containing triple therapy with esomeprazole-based levofloxacin-containing triple therapy for eradication of Helicobacter pylori infection in adults with dyspepsia. The main questions it aims to answer are whether vonoprazan-based triple therapy achieves a higher eradication rate of H.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Dyspeptic patients with positive for both rapid urease test and stool antigen test
- Patients giving written informed consent
You likely can't join if
- Treatment with a proton pump inhibitor, H2-receptor antagonist within the last 2 weeks, prior to the study
- Treatment with antibiotics or bismuth preparation within 4 weeks prior to the study
- Previous H. pylori eradication therapy
- Gastric or duodenal ulcer with current or recent bleeding on endoscopy
- Significant upper or lower gastrointestinal bleeding within 4 weeks
- Patients with regular intake of NSAIDs or steroids
See the full eligibility criteria
- Age ≥ 18 years
- Dyspeptic patients with positive for both rapid urease test and stool antigen test
- Patients giving written informed consent
- Treatment with a proton pump inhibitor, H2-receptor antagonist within the last 2 weeks, prior to the study
- Treatment with antibiotics or bismuth preparation within 4 weeks prior to the study
- Previous H. pylori eradication therapy
- Gastric or duodenal ulcer with current or recent bleeding on endoscopy
- Significant upper or lower gastrointestinal bleeding within 4 weeks
- Patients with regular intake of NSAIDs or steroids
- Surgery that might affect gastric acid secretion e.g., upper GI resection or vagotomy
- Known case of malignancy, including MALToma
- Advanced co-morbidities (e.g., CLD, CKD, cardio-respiratory failure, known thyroid disease)
- Chronic alcohol abuse, chronic illegal drug use, or drug addiction within the past 12 months
- Pregnant, lactating woman or intend to become pregnant within the study period
- History of hypersensitivity to vonoprazan, PPIs, amoxicillin, and/or levofloxacin
- On colchicine
- people with abnormal laboratory test at the start of the screening period: S. creatinine \> 2 mg/dl SGPT \> 2 x Upper limit of normal
The study team makes the final eligibility decision.
Where it's taking place
- Dhaka, Bangladesh
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dhaka, Bangladesh. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.