Vonoprazan In Real world evidence for Tolerability and efficacy in symptomatic management of reflUx Esophagitis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,800
- 试验地点
- 1
研究概览
简要总结
This is a retrospective observational study will conducted in India. Medical records of adults patients above or equal to 18 years age with reflux esophagitis will be screened, and eligible patients records who are not receiving other acid-altering medications and are treated with vonoprazan 20 mg once daily for four weeks will be included in the analysis. Primary outcomes assessed changes in Frequency Scale for the Symptoms of GERD (FSSG) scores from baseline to Weeks 2 and 4, as well as the proportion of patients achieving overall heartburn resolution at Week 2 and 4. Secondary outcomes are physician global assessment of treatment response and safety/tolerability based on recorded adverse drug reactions at week 2 and week 4
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •Medical records of adult patients equal or above 18 years of age with symptoms of reflux esophagitis and treated with vonoprazan 20 mg once daily as per local prescribing guidelines will be retrieved and screened for further analysis.
排除标准
- •Screened records will not be considered for evaluation if patients had esophageal comorbidities, prior gastrointestinal or esophageal surgery, recent use of acid-suppressing therapy, H.
- •pylori eradication within 28 days, significant hepatic dysfunction, inflammatory bowel disease, malignancy, or hypersensitivity to vonoprazan.
研究者
Dr Darshan Rana MBBS MD
Mankind Pharma Ltd