Authors: PAPPA; WILLIAMS; PAYNE; BUARON; MUSSARI; CIOCIOLA

Source: Alimentary Pharmacology & Therapeutics, Volume 13, Number 4, April 1999 , pp. 467-473(7)

Publisher: Wiley-Blackwell

Abstract:

Background

: Ranitidine 75 mg (Zantac 75) has been shown to be effective for the treatment of pre-existing heartburn symptoms. Aim

: To compare the efficacy of dosing ranitidine 75 mg or placebo 30 min prior to a proven heartburn-provoking meal in completely preventing or reducing subsequent heartburn symptoms. Methods

: A randomized, double-blind, parallel methodology was used at nine investigative centres. Following a screening visit, patients ate a standard test meal consisting of chilli, chips and a soft drink on two occasions. On the first occasion, patients received single-blind placebo 30 min before the meal. This meal was used to qualify patients and to ensure the onset of a minimum level of heartburn. Patients who qualified were randomized (n = 284) to receive double-blind ranitidine 75 mg or placebo 30 min before a second test meal administered 4-14 days later at the treatment visit. Patients 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 ranitidine 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 ranitidine 75 mg is effective in completely preventing or decreasing heartburn when administered 30 min prior to a provocative meal.

Document Type: Research article

DOI: http://dx.doi.org/10.1046/j.1365-2036.1999.00505.x

Affiliations: 1: Global OTC Clinical Development, Glaxo Wellcome Inc., Research Triangle Park, North Carolina, USA

Publication date: 1999-04-01

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