A SURVEILLANCE STUDY TO OBSERVE THE SAFETY AND EFFECTIVENESS OF A FIXED-DOSE COMBINATION OF SODIUM ALGINATE + SODIUM BICARBONATE + CALCIUM CARBONATE (ALGINATE RAFT-FORMING ORAL SUSPENSION) THERAPY IN PATIENTS DIAGNOSED WITH SYMPTOMS OF GASTRO-ESOPHAGEAL REFLUX DISEASE.
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Keywords
GERD, Gastrointestinal disorder, Fixed-Dose Combination, Sodium Alginate, Sodium Bicarbonate, Calcium Carbonate, Alginate Raft-forming Oral Suspension
Abstract
Aim & Objectives:
To observe the efficacy of a fixed dose combination of Sodium Alginate, Sodium Bicarbonate, and Calcium Carbonate therapy in patients with symptoms of heartburn, regurgitation, and indigestion (GERD). To observe patients’ safety and overall satisfaction, improvement in symptoms and improvement of quality of life following a 28-day treatment with a fixed dose combination of Sodium Alginate, Sodium Bicarbonate and Calcium Carbonate therapy. This study was sponsored by Espi Industries & Chemicals Pvt. Ltd. P-9/2, IDA, Uppal, Hyderabad.
Materials & Methods:
The product Sodium Alginate, Sodium Bicarbonate & Calcium Carbonate Oral Suspension was provided by ESPI Industries & Chemicals Pvt. Ltd. P-9/2, IDA, Uppal, Hyderabad. 100 eligible patients meeting inclusion/exclusion criteria were planned to be enrolled in selected sites to evaluate the effect of fixed-dose combination in patients with symptoms of heartburn, regurgitation, and indigestion. A total of 100 patients were enrolled in this study. As per sample size determination, a sample size of 100 patients was needed. Study data were collected at baseline, week 02 and week 04. Subjects were under direct medical care during the entire study period. The time points of interest for data collection were at baseline at the introduction of the Study product, day 14 and day 28 (End of study).
Results:
The primary efficacy variable of this study i.e., the Mean total score of heartburn/regurgitation was 12.32 at baseline. After 28 days of treatment, the mean total score of heartburn/regurgitation showed a significant fall of 86.2% from baseline. The secondary efficacy variable of this study was the mean total score of upper gastrointestinal disorders-Quality of Life (PAGI-SYM), (PAGI-QOL) from baseline to day 14 and day 28 which showed significant fall and for Treatment satisfaction Questionnaire from day 14 to day 28 patients exhibited treatment satisfaction.
Conclusion:
Fixed-dose combination of Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate therapy showed a significant reduction of upper gastrointestinal disorder symptoms and Quality of life along with treatment overall satisfaction at day 28 was found to be effective, safe and well tolerated in the study population. The percentage of patients from amongst the study population who were relieved of symptoms within 5 minutes of administration of the Fixed-Dose Combination was 75.52%. 80.61% of the study population experienced relief for a period of 2 to 4 hours after administration of the Fixed Dose Combination.
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B.N. Harisha
QC Manager, Espi Industries & Chemicals Private Limited, P-9/2, IDA, Uppal, Hyderabad-500039, India