A double-masked, placebo-controlled study of the efficacy and safety of premeal ranitidine in the prevention or reduction of heartburn

Abstract

Ranitidine 75 mg has been shown previously to be effective for the treatment of existing heartburn symptoms. In the present study, the efficacy and safety of ranitidine 75 mg in preventing or reducing heartburn symptoms were assessed when the study medication was taken 60 minutes before a meal. A total of 296 adult patients were compared in a randomized, parallel-group, double-masked, placebo-controlled, multicenter study. A standard provocative meal was consumed on two occasions separated by at least 4 days. The qualifying meal followed administration of single-masked placebo, while the randomized meal followed administration of double-masked study medication. Patients reported the presence or absence of heartburn, and completed a 100-mm visual analogue scale (VAS) to record the presence of heartburn and their level of heartburn discomfort. The primary end point was heartburn severity calculated as area under the concentration—time curve (AUC) for the assessment period. Study findings demonstrated that the heartburn severity AUC was significantly lower in ranitidine-treated patients than in the placebo group. The success rates for four clinical end points were significantly higher in the ranitidine group than in the placebo group. Significant differences favoring ranitidine 75 mg were also observed for the secondary end points of percent reduction in heartburn severity AUC, peak VAS heartburn severity, percent reduction in peak VAS heartburn severity, distribution of patients' global efficacy ratings of study medication, and overnight VAS heartburn severity. The overall incidence of adverse events was low following double-masked treatments (1% for ranitidine 75 mg and 2% for placebo). The study findings demonstrate clearly that ranitidine 75 mg is effective and safe in significantly reducing heartburn severity in adult patients when administered 60 minutes before a provocative meal