Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication

Asian Institute of Gastroenterology, India

Status and phase: Active, not recruiting; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06959368

VECTOR-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 484 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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484 participants in 2 patient groups

Vonoprazan triple therapy

Active Comparator group

Description:

• Vonoprazan Triple Therapy: Vonoprazan 20 mg, Amoxicillin 1 g, Clarithromycin 500 mg (all twice daily).

Treatment:

Drug: Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg

Standard triple therapy

Active Comparator group

Description:

• Standard Triple Therapy: Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg (all twice daily).

Treatment:

Drug: Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg