Prospective, observational, multi-center, post-marketing surveillance to measure the effectiveness of Omeprazole and Domperidone combination therapy on patient reported outcome measures in gastro-esophageal reflux disease

Dr Reddys Laboratories Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Subjects of either sex diagnosed with gastro-esophageal reflux disease, aged >=18 years and <=65 years
•2.Patient who has been prescribed Omeprazole and Domperidone combination therapy as routine clinical management as per Investigator discretion.
•3.Subjects must be willing to give consent in writing to participate in the study by signing the Informed Consent Form (ICF)

•1.Hyper-sensitivity to any Proton pump inhibitor including omeprazole in the past
•2.Participated in an investigational drug or investigational device study within 30 days prior to the start of the study
•3.Used histamine 2 receptor blockers, over the counter antacids, anticholinergics, cholinergics, spasmolytics, opiates, sucralfate, prokinetics, antibiotics or bismuth compounds within 14 days prior to the start of the study
•4.Any medical condition according to PI which may interfere with the treatment and makes the subject ineligible for participation in study.
•5.Subjects not having sufficient educational level and proficiency in reading and writing in their local language to be capable of reliably completing study questionnaires, as judged by the physician
•6.Female subjects who are pregnant or breast-feeding.

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