Recruiting PHASE4 Helicobacter Pylori Infection

Compares treatment options for Helicobacter Pylori Infection

Official title Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication

ClinicalTrials.gov ID: NCT06959368

What this study is testing

What is Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg?

Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg 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
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).
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 80

You may be able to join if

  • 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

You likely can't join if

  • 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
See the full eligibility criteria
Who can 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
What rules you out
  • 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
  • Patient on anticoagulation, NSAIDs
  • Patient using drugs with interactions with vonoprazan, amoxicillin, clarithromycin or PPIs
  • Cirrhosis, Chronic kidney disease, chronic lung disease

The study team makes the final eligibility decision.

Where it's taking place

  • Hyderabad, Telangana, India

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 to 80 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Hyderabad, Telangana, India. 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.