Efficacy and Safety of Vonoprazan versus Omeprazole in Pharmacotherapy of H. pylori-Induced Peptic Ulcer in Eastern India
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 2 weeks
次要结局
- 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)
研究者
Dr Bazla Nazir
Indira Gandhi Institute Of Medical Sciences