Health Condition 1: K929- Disease of digestive system, unspecified
Conditions
Interventions
Intervention1: Sodium Alginate IP 500 mg, Sodium Bicarbonate IP 213 mg and Calcium Carbonate IP 325 mg per 10 mL: Each patient will take the FDC oral suspension (10-20 mL after meals and at bedtime, u
Sponsors
Naxpar Pharma Pvt. Ltd,
Naxpar Pharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: A patient will be considered eligible for inclusion in the study if he/she fulfils the following criteria: 1.Male and female patients =18 years and up to 60 years of age. 2.Patients diagnosed with heartburn and indigestion who have been prescribed the FDC oral suspension as per the approved prescribing information in accordance with clinical practice. 3.Patients willing to sign patient authorization form (PAF).
Exclusion criteria
Exclusion criteria: 1.Patients will not be considered eligible for inclusion in this study if they meet any of the following criteria: 2.Patients with highly restricted salt/sodium diet e.g., cases of congestive cardiac failure, renal impairment, hypertension, and edema states. 3.Patients with history or ongoing illness of hypercalcemia, nephrocalcinosis, and recurrent calcium containing renal calculi. 4.Patients with history of known or suspected hypersensitivity to the active substances or any of the excipients; or suffering from any other conditions or diseases that an investigator considers as inappropriate to enter the study as per the approved prescribing information. 5.Patients taking any medications (e.g., proton pump inhibitors, H2 receptor blocking agents, antacids, or prokinetic agents) which might interfere with the action of the FDC oral suspension prior to the start of the study. 6.Female patients who are pregnant or are nursing mothers. 7.Patients who are determined to be at risk of COVID-19 as per investigator discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and percentage of patients with adverse drug reactions (ADRs) and/or Other Pharmacovigilance- Relevant Information (OPRIs)Timepoint: Number and percentage of patients who discontinue study treatment due to ADRs and/or OPRIs Global tolerability assessment by patients and investigators after 7 days of treatment on a 3-point scale ranging from ?good ? to ?poor ? tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving adequate heartburn or indigestion relief after 7 days of treatment. Adequate heartburn or regurgitation relief was defined as no more than 1 day of mild heartburn or regurgitation episodes during the past 7 days post baseline visit. Timepoint: Percentage of patients achieving adequate heartburn or indigestion relief after 7 days of treatment. Adequate heartburn or regurgitation relief was defined as no more than 1 day of mild heartburn or regurgitation episodes during the past 7 days post baseline visit. Daily severity of symptom according to the following four-point scale 0 none (no symptom) 1 mild symptom were easily tolerated, the discomfort was only minimal and did not affect normal activities 2moderate symptoms were | — |
Countries
India
Contacts
Public ContactDr Jayashri Krishnan
JSS Medical Research Asia pacific Private Limit
Outcome results
None listed