Status:
RECRUITING
Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication
Lead Sponsor:
Asian Institute of Gastroenterology, India
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 25 2026
Estimated Enrollment :
484 Patients enrolled
Trial Details
Trial ID
NCT06959368
Start Date
March 25 2025
End Date
March 25 2026
Last Update
June 11 2025
Active Locations (1)
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1
AIG hospitals
Hyderabad, Telangana, India, 500082