Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitis
Conditions
Interventions
Intervention1: Fixed Dose Combination of Sodium Alginate 250 mg, Sodium Bicarbonate 106.5 mg and Calcium Carbonate 187.5 mg Chewable tablets: Patients will be instructed to administer Fixed Dose Combi
Sponsors
AKUMS DRUGS & PHARMACEUTICALS LIMITED
Akums Drugs Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female patients more than 18 years of age. 2. Patients who have been prescribed FDC of Sodium Alginate Sodium Bicarbonate and Calcium Carbonate Chewable tablets for the treatment of reflux related symptoms in line with the marketing authorization during the last 24 hours prior to the study screening. 3. Patients who have experienced reflux related symptoms such as heartburn and or regurgitation during the 48-hour prior to the study screening. 4. Patients willing to sign informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with highly restricted salt/sodium diet e.g., in some cases of cardiac failure, renal impairment, hypertension, and edema states. 2. Patients with known cases of hypercalcemia, nephrocalcinosis and recurrent calcium containing renal calculi. 3. Patients with known or suspected hypersensitivity to the active substance or any of the excipients. 4. Patient who has taken FDC of Sodium Alginate, Sodium Bicarbonate and Calcium Carbonate Chewable tablets during the last 12 weeks (except for the previous 24 hours), 5. Patients with any other conditions or diseases that an investigator considers it as inappropriate to enter the study as per the approved label. 6. Patients taking any medications which might interfere with the action of sodium alginate Chewable tablets prior to the start of the study. 7. Patient with history of received an investigational product or participation in another trial involving a marketed or investigational drug in the past 90 days prior to screening. 8. Patients who have an employee at the site or a partner or first-degree relative of the investigator. 9. Patient who has already previously enrolled in this study. 10. Female patients who are pregnant or planning to become pregnant or nursing mothers. 11. Patient not willing to comply with all aspects of the protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate proportion of patients with adverse events reported during the study.Timepoint: Visit 2 (Day 0), Visit 3 (Day 7) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Safety Endpoints (assessment of Laboratory parameters, Vital signs) Timepoint: Visit 2 (Day 0), Visit 3 (Day 7) ;Change in Modified DeMeester clinical symptoms score of heartburn & regurgitation Timepoint: Visit 2 (Day 0), Visit 3 (Day 7);Change in Modified FSSG ScoreTimepoint: Visit 2 (Day 0), Visit 3 (Day 7);Patients overall satisfaction at the end of study.Timepoint: Visit 3 (Day 7) | — |
Countries
India
Contacts
Public ContactDr Aditi Datta
Biosite Research Private Limited
Outcome results
None listed