A Randomised Controlled Trial Comparing Vonoprazan Triple Therapy (Vonoprazan, Amoxicillin, Clarithromycin), and Standard Triple Therapy (Esomeprazole, Amoxicillin, Clarithromycin) for Helicobacter Pylori Eradication in Indian Population. VECTOR Trial - Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
India
AIG hospitals
RECRUITING
Hyderabad
Contact Information
Primary
Krithi Krishna Koduri Doctor
drkrithivk@gmail.com
+91 9870083545
Time Frame
Start Date: 2025-03-25
Estimated Completion Date: 2026-03-25
Participants
Target number of participants: 484
Treatments
Active_comparator: Vonoprazan triple therapy
• Vonoprazan Triple Therapy: Vonoprazan 20 mg, Amoxicillin 1 g, Clarithromycin 500 mg (all twice daily).
Active_comparator: Standard triple therapy
• Standard Triple Therapy: Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg (all twice daily).
Sponsors
Leads: Asian Institute of Gastroenterology, India

This content was sourced from clinicaltrials.gov

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