A Phase IV, Post-marketing, Prospective, Multicentric, Single Arm Study to Evaluate the Safety and Efficacy of Vonoprazan 20mg in Adult Patients with Approved Indications.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Treatment emergent clinical & laboratory adverse events (TEAEs) during the
研究概览
简要总结
This Phase IV, post-marketing, prospective, multicentric, single-arm study is designed to assess the safety and efficacy of Vonoprazan 20 mg in adult patients diagnosed with gastroesophageal reflux disease (GERD). Participants will be instructed to take one tablet of Vonoprazan 20 mg orally each morning, consistently after their meal. The primary endpoint of the study will focus on the evaluation of treatment-emergent clinical and laboratory adverse events (TEAEs) throughout the treatment duration. Secondary endpoints will include the change in the GERD-FSSG score from baseline to the end of 4 weeks, the change in the GERD-FSSG score from baseline to the end of 8 weeks, and the proportion of patients achieving complete resolution of heartburn and regurgitation at both the 4-week and 8-week marks. The study aims to enroll participants from 8 to 10 sites across India, ensuring their eligibility based on established inclusion and exclusion criteria. After 9 weeks of study period, the results will be analyzed and the data will be presented for product approval.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male or female patients aged of 18-65 years.
- •Patients willing to give written, signed, and dated informed consent to participate in the study.
- •Patients with Reflux esophagitis (RE)/Gastric Ulcer (GU)/Duodenal Ulcer (DU)/prevention of gastric ulcer or duodenal ulcer during low dose aspirin/administration and NSAIDs administration/adjunct to helicobacter pylori eradication associated with gastric ulcer, duodenal ulcer/ gastric MALT (mucosa-assisted lymphoid tissue) lymphoma, idiopathic thrombocytopenia purpura/ stomach after endoscopic resection of early stage cancer or helicobacter pylori gastritis.
- •Patients (Women of childbearing potential and their partners) must agree to use barrier contraception during the study period and for 3 months afterward and neither become pregnant or lactate.
排除标准
- 未提供
结局指标
主要结局
Treatment emergent clinical & laboratory adverse events (TEAEs) during the
时间窗: At the end of the Week 4 and week 8
treatment period.
时间窗: At the end of the Week 4 and week 8
次要结局
- 1. Change in GERD-FSSG score from baseline to end of 4(weeks.)
- 2. Change in GERD-FSSG score from baseline to end of 8(weeks.)
- 3. Proportion of patients with complete resolution of heartburn(and regurgitation after 4 weeks and 8 weeks.)
研究者
Dr Shubhadeep Sinha
Hetero Labs Limited