Management of severe erosive gastroesophageal reflux disease (eGERD) with high-dose proton pump inhibitors: A real-world observational study (POWER 3.0)

Dr Reddys Laboratories Limited34 个研究点分布在 1 个国家目标入组 500 人开始时间: 2025年3月17日最近更新: 2025年3月4日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Dr Reddys Laboratories Limited
入组人数: 500
试验地点: 34
主要终点: 1. Proportion of subjects with severe erosive GERD based on severity of diurnal symptoms heartburn, regurgitation, epigastric distress, and dysphagia graded as follows at baseline, 4 week, and 8 week-

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This prospective, observational study will enrol patients clinically diagnosed with severe erosive GERD and satisfying all eligibility criteria. Demographic details (age, gender, height, and weight), information on lifestyle (meal, sleep, smoking, drinking, stress, exercise, etc.), comorbid medical conditions, concomitant medications, and details on GERD and PPI consumption will be collected at baseline. Patients will treated with high dose PPI as per physician’s discretion and the will be monitored to evaluate protocol-defined study outcomes. The patients will be divided into three cohorts based on the prescribed PPIs for analysis purpose.

The severity of symptoms (heartburn, regurgitation, epigastric distress, and dysphagia) will be assessed using a Likert scale. Quality of life will be assessed based on QOLRAD-RI. Data on treatment compliance and

satisfaction will also be collected from patients. Safety will be assessed based on the incidence rate of AEs. Data will be accrued at 4±1 weeks

and 8±1 weeks. Endoscopy results, if available, will be retrieved and analyzed.

研究设计

研究类型: Observational

入排标准

年龄范围: 18.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•Male or female greater than equal to 18 years
•Patients diagnosed with severe erosive GERD by treating physician
•Patients who were on regular dose of PPI (Rabeprazole 20mg, Pantoprazole 40mg, Omeprazole 20mg/Esomeprazole 40mg) as initial therapy for the last
•8 weeks and with incomplete symptomatic relief OR Patients who will be commenced on high dose of PPI (Rabeprazole 40mg, Pantoprazole 80mg, Omeprazole 40mg/Esomeprazole 80mg) as initial therapy
•Willingness to provide written informed consent.

排除标准

•Patients with complications associated with GERD (esophageal stricture, Barretts esophagus, esophagitis and asthma) organic causes
•Patients with known history of surgical management of GERD
•Patients with known history of high-dose PPI usage
•Refusal or inability to comply with the requirements of the protocol for any reason, including answering questionnaires
•Any other condition(s) that would make the patient, in the opinion of the Investigator, unsuitable for the study.

结局指标

主要结局

1. Proportion of subjects with severe erosive GERD based on severity of diurnal symptoms heartburn, regurgitation, epigastric distress, and dysphagia graded as follows at baseline, 4 week, and 8 week-

时间窗: 4 week, and 8 week

Absent, score 0

时间窗: 4 week, and 8 week

Mild, score 1, awareness of symptom, but easily tolerated

时间窗: 4 week, and 8 week

Moderate score 2, discomfort sufficient enough to cause interference with normal activities, including sleep

时间窗: 4 week, and 8 week

Severe, score 3, incapacitating, with inability to perform normal activities, including sleep

时间窗: 4 week, and 8 week

Primary Outcome Continued