A comparative study of Vonoprazan-based Hybrid therapy Vs Vonoprazan-based Dual Therapy as First line treatment for H. pylori: A open label, non-inferiority randomized controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 1
研究概览
简要总结
A Comparative study of Vonoprazan-based Hybrid therapy Vs Vonoprazan-based Dual therapy as First Line treatment for H. pylori: An Open-label, Non-inferiority randomized controlled trial. The primary outcomes is toCompare H. pylori eradication rate at week 6 post-therapy between Vonoprazan-based Hybrid therapy and Vonoprazan-based Dual therapy, the secondary outcomes are determination of the incidence and severity of Adverse event using the common terminology criteria for adverse events (CTCAE) version 5.0, and GI symptoms changes via Gastrointestinal symptom rating scale (GSRS) at Baseline, Day 14, Week 6, and to evaluate the patient adherence (Pill count, diaries etc., and to perform cost-eradication analysis which include drug cost and adverse event management expenses. This study is conducted for a duration of 1 year. This study gives a better cost-effectiveness considering drug use and other healthcare cost, and lays foundation for generation of Indian-specific clinical evidence to guide future H. pylori treatment protocol and support rational antibiotic use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age above 18 years.
- •1.Treatment-naïve H.
- •pylori infection confirmed by: Endoscopy or Stool antigen test positive.
- •2.Willing and able to attend day 14 and Week 6 visit.
排除标准
- •1.Patient received prior H.
- •pylori eradication therapy.
- •2.Patient with known allergies to Penicillins, Metronidazole, or Vonoprazan.
- •3.Pregnant and Lactating women.
- •4.Any Active upper GI bleeding, perforated Ulcer, or histologically confirmed gastric malignancy (Past records).
- •5.Patients on Immunosuppressive therapy.
- •7.Patients with known or suspected gastric malignancy.
研究者
Dr Kishor H
PES University Institute of Medical Sciences and Research