Efficacy and Safety of Vonoprazan versus Omeprazole in Pharmacotherapy of H. pylori-Induced Peptic Ulcer in Eastern India
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dr Bazla Nazir
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The proportion of patients achieving clinical cure (resolution of peptic ulcer symptoms) at the end of pharmacotherapy (14th day) for Vonoprazan triple therapy compared to Omeprazole triple therapy.
Overview
Brief Summary
This randomized controlled trial investigates the comparative efficacy and safety of vonoprazan versus omeprazole, both combined with amoxicillin and metronidazole, for treating H. pylori-induced peptic ulcer disease (PUD) in Eastern India. Targeting the challenges of PPI resistance and regional treatment inefficacy, it evaluates clinical cure rates, H. pylori eradication (via UBT/RUT), endoscopic ulcer grading, patient-reported outcomes, and adverse event profiles across 100 adult participants. With vonoprazan’s CYP2C19-independent, rapid, and sustained acid suppression effects, the study hypothesizes superior symptom relief, ulcer healing, and tolerability compared to omeprazole. Outcomes may inform improved clinical guidelines and tailored therapeutic strategies for high-burden populations.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients willing to provide informed consent and adhere to study protocols.
- •Patients with a confirmed diagnosis of H.
- •pylori infection via urea breath test, stool antigen test, or histological examination.
Exclusion Criteria
- •1.Patients with a history of allergy or intolerance to vonoprazan, omeprazole, or related compounds.
- •2.Patients currently using other proton pump inhibitors or H2 receptor antagonists within 2 weeks before the study.
- •3.Patients with a history of gastric surgery or previous H.
- •pylori eradication therapy.
- •4.Patients with severe comorbidities such as liver, kidney, or heart diseases.
- •5.Pregnant or lactating women.
- •6.Patients unable or unwilling to comply with study procedures and follow-up visits.
Outcomes
Primary Outcomes
The proportion of patients achieving clinical cure (resolution of peptic ulcer symptoms) at the end of pharmacotherapy (14th day) for Vonoprazan triple therapy compared to Omeprazole triple therapy.
Time Frame: 2 weeks
Secondary Outcomes
- H. pylori eradication (negative UBT and RUT post-treatment)(baseline and 2 weeks)
- Endoscopic grading (Forrest Classification)(baseline and 2 weeks)
- quality of life assessment using validated tool: SF-36(2 weeks)
- Incidence of adverse effects using WHO UMC causality assessment scales(baseline to 2 weeks)
Investigators
Dr Bazla Nazir
Indira Gandhi Institute Of Medical Sciences