H. pylori Screening and Treatment for Helicobacter Pylori Infection

Overseen By Angie Gaitan

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Miami

Must not be taking: Statins, Benzodiazepines, Antipsychotics, others

Disqualifiers: Gastric cancer, Pregnancy, Severe kidney impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Duration not specified

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on detecting a stomach infection called H. pylori, which can cause gastritis, stomach ulcers, or even cancer. Participants who test positive will receive VOQUEZNA® Triple Pak®, a combination therapy for H. pylori infection, to help prevent these issues. A simple breath test identifies the infection. The trial suits adults who have not previously received H. pylori treatment and have no history of stomach cancer or severe liver or kidney problems. As a Phase 4 trial, it involves an FDA-approved treatment, aiming to understand its benefits for more patients.

Will I have to stop taking my current medications?

If you are taking any of the medications listed in the exclusion criteria, you will need to stop them to participate in the trial. These include certain heart medications, statins, and others. It's best to discuss with the trial team to see if your current medications are on the list.

What is the safety track record for VOQUEZNA® Triple Pak®?

Research has shown that VOQUEZNA® Triple Pak® was tested for safety in a study involving 675 adults treated for H. pylori infections. This treatment includes three medications: vonoprazan, amoxicillin, and clarithromycin. Most participants tolerated it well, but some experienced side effects such as headaches, changes in taste, and diarrhea.

Serious concerns arise when it interacts with other medications. For instance, taking clarithromycin with certain cholesterol-lowering drugs can lead to severe side effects. Therefore, informing the study team about any other medications being taken before starting treatment is crucial.

Overall, VOQUEZNA® Triple Pak® is considered safe for many people, but monitoring for any side effects and consulting healthcare providers if concerns arise is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatment options for Helicobacter pylori infection, which often include various combinations of antibiotics and acid reducers like clarithromycin, amoxicillin, and proton pump inhibitors, VOQUEZNA® Triple Pak® is noteworthy for its comprehensive approach. This treatment combines vonoprazan, a novel potassium-competitive acid blocker, with amoxicillin and clarithromycin, offering potentially enhanced acid suppression. Researchers are excited about VOQUEZNA® because vonoprazan provides a more stable gastric environment, which may improve the effectiveness of antibiotics in eradicating H. pylori. This could lead to better treatment outcomes and reduced rates of infection recurrence.

What is the effectiveness track record for VOQUEZNA® Triple Pak® in treating H. pylori infection?

Research has shown that VOQUEZNA® Triple Pak® effectively treats Helicobacter pylori (H. pylori) infection, which participants in this trial will receive if they test positive. Studies have found that this treatment successfully eradicates the infection in about 8 out of 10 people without resistant strains, achieving an eradication rate of 80.8%. Another study reported similar results, with an eradication rate of 84.7% for non-resistant strains. The FDA has approved VOQUEZNA® Triple Pak®, confirming its effectiveness in treating this infection. ^{6 7 8 9 10}

Who Is on the Research Team?

Shria Kumar, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for individuals at risk of stomach issues in South Florida. It's focused on finding and treating Helicobacter pylori, a stomach infection linked to gastritis, ulcers, and cancer. Participants will be screened for H. pylori and treated if positive.

Inclusion Criteria

I am 18 years old or older.

Exclusion Criteria

Prisoners

Pregnant women, those who are breastfeeding, or those who are planning to become pregnant/breastfeed

I have had gastric cancer in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants who test positive for H. pylori receive VOQUEZNA® Triple Pak® therapy

Duration not specified

1 visit (in-person) for diagnosis and treatment initiation

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VOQUEZNA® Triple Pak®

Trial Overview The study uses the PYTEST® 14C-Urea Breath Test to detect H. pylori infection. Those who test positive are then treated with VOQUEZNA® Triple Pak®, which aims to eradicate the infection and prevent related diseases.

How Is the Trial Designed?

Group I: Helicobacter Pylori Screening and Treatment Experimental Treatment 2 Interventions

Participants in this single-arm study will undergo screening for Helicobacter pylori (H. pylori) using the PYtest® 14C-Urea Capsule Breath Test. This FDA-approved, non-invasive diagnostic method involves swallowing a radiolabeled urea capsule. If gastric urease from H. pylori is present, the urea is hydrolyzed to produce carbon dioxide and ammonia. Ten minutes after ingestion, a breath sample is collected in a balloon and transferred into a collection fluid to trap the labeled carbon dioxide. The sample is analyzed using a liquid scintillation counter to determine infection status. Participants who test positive will receive VOQUEZNA® Triple Pak® therapy, dispensed by the study team at the time of diagnosis. Phathom Pharmaceuticals will supply the medications (which include complete medication package insert), but the study team hold and dispenses medications.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Phathom Pharmaceuticals

Collaborator

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Citations

1. voqueznapro.com voqueznapro.com/h-pylori/study-design

H. pylori Treatment Study | VOQUEZNA® Triple Pak ... A randomized, controlled, double-blind triple therapy/open-label dual therapy study that evaluated the effectiveness and safety of VOQUEZNA® Triple Pak®

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35679950/

Vonoprazan Triple and Dual Therapy for Helicobacter ... Primary outcome eradication rates (nonresistant strains): vonoprazan triple therapy 84.7%, dual therapy 78.5%, vs lansoprazole triple therapy ...

3. fda.gov fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-voquezna-triple-pak-voquezna-dual-pak

Drug Trials Snapshots: VOQUEZNA TRIPLE PAK ... The primary efficacy endpoint was H. pylori eradication rate in subjects who did not have a clarithromycin or amoxicillin-resistant strain of H.

4. investors.phathompharma.com investors.phathompharma.com/news-releases/news-release-details/phathom-pharmaceuticals-announces-fda-approval-reformulated

News Release pylori. The H. pylori eradication rate with VOQUEZNA TRIPLE PAK was 80.8% versus 68.5% with lansoprazole triple therapy in the overall study ...

5. gi.org gi.org/journals-publications/ebgi/schoenfeld_july2022/

Treating Helicobacter pylori Infection with Vonoprazan Outcome: The primary endpoint was H. pylori eradication based on negative 13C-urea breath test obtained at least 4 weeks after last dose of ...

6. voquezna.com voquezna.com/hp/important-safety-information/

Important Safety Information | VOQUEZNA® TRIPLE PAK® ... Serious adverse reactions can occur with VOQUEZNA TRIPLE PAK due to drug interactions of clarithromycin with colchicine, some lipid lowering agents, some ...

7. voqueznapro.com voqueznapro.com/h-pylori

H. pylori Treatment | VOQUEZNA® Triple Pak® (vonoprazan ... VOQUEZNA DUAL PAK is a co-packaged product containing vonoprazan and amoxicillin. Both products are indicated for the treatment of Helicobacter pylori infection ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/215152s015,215153s014lbl.pdf

highlights of prescribing information - accessdata.fda.gov The safety of VOQUEZNA TRIPLE PAK was evaluated in 675 adult patients (aged 20 to 82 years) in clinical trials in the United States, Europe and Japan and ...

9. voquezna.com voquezna.com/hp/about-h-pylori/

About H. Pylori What is H. Pylori infection? Learn about H. Pylori symptoms, how the bacteria are eradicated, and more. Please see full safety and prescribing information.

10. webmd.com webmd.com/drugs/2/drug-184216/voquezna-triple-pak-oral/details/list-sideeffects

Voquezna Triple Pak (vonoprazan, amoxicillin, and ... Overview: Voquezna Triple Pak is used to treat an infection in the stomach caused by bacteria called Helicobacter pylori (H. pylori). It ...