A double-blind, placebo-controlled study of the efficacy and safety of non-prescription XXXX 75 mg in the prevention of meal-induced heartburn.

@entity1 @entity5616 @entity11068
BACKGROUND: @entity5616 75 mg (Zantac 75) has been shown to be effective for the treatment of pre-existing @entity11068 . AIM: To compare the efficacy of dosing @entity5616 75 mg or placebo 30 min prior to a proven heartburn-provoking meal in completely preventing or reducing subsequent @entity11068 . METHODS: A randomized, double-blind, parallel methodology was used at nine investigative centres. Following a screening visit, @entity1 ate a standard test meal consisting of chili, chips and a soft drink on two occasions. On the first occasion, @entity1 received single-blind placebo 30 min before the meal. This meal was used to qualify @entity1 and to ensure the onset of a minimum level of heartburn. @entity1 who qualified were randomized (n = 284) to receive double-blind @entity5616 75 mg or placebo 30 min before a second test meal administered 4-14 days later at the treatment visit. @entity1 recorded whether heartburn was present and rated heartburn severity by completing visual analogue scales at 15-min intervals over the 4. 5 h meal evaluation periods. RESULTS: Statistically significant differences favouring @entity5616 75 mg were determined for complete prevention of heartburn (P < 0.006), heartburn severity area under the curve (P < 0.001), a clinical success end-point (P < 0.001), and all other end-points (P < 0.001). CONCLUSIONS: These data clearly demonstrate that @entity5616 75 mg is effective in completely preventing or decreasing heartburn when administered 30 min prior to a provocative meal.
