CTRI/2020/04/024623
Recruiting
Phase 4
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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitis
- Sponsor
- Dr Reddys Laboratories Ltd
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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