This study will observe the effectiveness of combination treatment of Omeprazole and Domperidone in gasrtic disease

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

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/04/024623

Enrollment

400

Registered

2020-04-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitis

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects of either sex diagnosed with gastro-esophageal reflux disease, aged >=18 years and 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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

India

Contacts

Public ContactSucheta Pandit

Dr Reddys Laboratories Ltd

amey.mane@drreddys.com04049048400

Outcome results