Open Safety-In-Use Trial of a New High-Potency Antacid Product

Abstract

In an open safety-in-use study, the subjective effectiveness and taste acceptability of a new high-potency antacid product were compared to previous treatment in 109 patients presenting with upper gastro-intestinal disorders of functional origin. Severity of the dominant symptoms prior to treatment was compared with that of symptoms present during treatment. Sixty-seven per cent to 73% of upper gastro-intestinal tract symptoms were completely relieved. Eighty-three per cent versus 48% of patients seen in a private practice setting, as compared with the speciality practice, reported good to excellent results, with 92% versus 56% describing good to excellent taste acceptability. When compared with previous antacid therapy, 70% of the patients preferred the new high-potency formulation to the regular-strength products, for both effectiveness and taste. The incidence of product-related side effects was low, with only 6·7% experiencing the diarrhoea or loose stools commonly associated with conventional products containing magnesium hydroxide.