Health Condition 1: null- Burning pain in the chest that may extend to the neck or base of the throat
Conditions
Interventions
None listed
Sponsors
Dr Reddys Laboratories
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female adult patients >=18 â?? 75 years of age 2. Subjects must present to the clinic with predominant symptoms of heartburn with or without regurgitation that they have experienced for the last 30 days with an increased frequency of up to >2 days in the last 7 days prior to their baseline visit. 3. Patient who has been prescribed omeprazole 20 mg (as per label) 4. Treatment naïve patients (i.e. patients who have not received regular treatment for their symptoms of heartburn in the last one month) 5. Participants must have adequate visual and auditory acuity (corrective glasses or hearing aids) to allow for participation, as judged by a clinician 6. Participants must have sufficient educational level and proficiency in reading and writing in their local language to be capable of reliably completing study questionnaires, as judged by a clinician 7. Subjects must consent in writing to participate in the study by signing and dating the Informed Consent Form (ICF) indicating that the subject has been informed of all pertinent aspects of the study prior to participation.
Exclusion criteria
Exclusion criteria: Patients will be excluded if they: 1. Participated in an investigational drug or investigational device study within 30 days prior to the start of the study 2. Prior treatment for heartburn symptoms with omeprazole or other PPIs or had used >3 doses of over the counter histamine-2 receptor antagonists or PPI during the week immediately before the study 3. Used anticholinergics, cholinergics, spasmolytics, opiates, sucralfate, prokinetics, antibiotics or bismuth compounds within 14 days prior to the start of the study 4. Hyper-sensitivity to any PPI including omeprazole in the past 5. Other gastrointestinal conditions in the past 12 months 6. History of conditions such as Barretâ??s oesophagus ( >3 cm), Zollinger-Ellison Syndrome, Scleroderma 7. History of cancer (other than non-melanoma skin cancers) present within the last 5-years which in the opinion of investigator can interfere with the patientâ??s participation in the study 8. History of significant trauma or surgery to the abdomen within the previous year 9. Planned surgical procedure during the duration of the study 10. History of cardiac diseases including ischemic heart disease, peripheral arterial disease, angina, myocardial infarction, transient ischemic attacks, stroke, congestive heart failure, etc 11. Special patient populations such as children, elderly patients ( >75 years of age), patients with renal dysfunction, patients with hepatic dysfunction, women who are pregnant or breast-feeding and women who could become pregnant during the study 12. History of alcohol or drug abuse as assessed by the investigator 13. History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder,including but not limited to: - Psychotic disorders; - Somatoform disorders; - Bipolar disorders; - Any other psychiatric illness that in the opinion of the Investigator would render a subject unsuitable to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resolution of heartburn symptoms in terms of frequency and severity; improvement in work productivity and satisfaction with treatmentTimepoint: Patients will complete the Short Form Leeds Dyspepsia Questionnaire (LDQ-SF)at baseline and two weeks post omeprazole treatment or possibly at four weeks They will also complete the Work Productivity and Activity Impairment questionnaire (WPAI) at baseline and at two weeks or possibly four weeks post initiation of treatment Treatment satisfaction questionnaire will be completed only at two weeks or possibly four weeks post initiation of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess patientâ??s satisfaction with omeprazole treatmentTimepoint: week 2 and possibly at week 4. | — |
Countries
India
Contacts
Public ContactRitesh Khandelwal
Dr Reddys Laboratories
Outcome results
None listed