This study will observe the effectiveness of combination treatment of Omeprazole and Domperidone in gasrtic disease
- Conditions
- Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitis
- Registration Number
- CTRI/2020/04/024623
- Lead Sponsor
- Dr Reddys Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the symptom improvement score using Patient Assessment of Gastrointestinal Disorder Symptom Severity Index (PAGI-SYM) questionnaire at Day 14Timepoint: Baseline, Day 14
- Secondary Outcome Measures
Name Time Method To evaluate the impact on quality of life of patient using Patient Assessment of Upper Gastrointestinal Disorder-Quality of Life (PAGI-QOL) questionnaire at Day 28Timepoint: Baseline, Day 28;To evaluate the patientâ??s overall treatment satisfaction on Day 14Timepoint: Day 14;To evaluate the patientâ??s overall treatment satisfaction on Day 28Timepoint: Day 28;To evaluate the symptom improvement score using Patient Assessment of Gastrointestinal Disorder Symptom Severity Index (PAGI-SYM) questionnaire at Day 28Timepoint: Baseline, Day 28