Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAsian Institute of Gastroenterology, India

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Penicillin allergy

Recent use of antibiotics in the past 1 month

Previous H. pylori therapy

Intestinal metaplasia, gastric cancer, bleeding peptic ulcer

Trial design

Treatments tested in this trial

  • Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg

Treatment groups

484 Participants
are divided into 2 treatment groups