Ka. Pappa et al., A double-blind, placebo-controlled study of the efficacy and safety of non-prescription ranitidine 75 mg in the prevention of meal-induced heartburn, ALIM PHARM, 13(4), 1999, pp. 467-473
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 p
rior to a proven heartburn-provoking meal in completely preventing or reduc
ing 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, O
n 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 se
cond test meal administered 4-14 days later at the treatment visit, Patient
s recorded whether heartburn was present and rated heartburn severity by co
mpleting visual analogue scales at 15-min intervals over the 4.5 h meal eva
luation periods.
Results: Statistically significant differences favouring ranitidine 75 mg w
ere determined for complete prevention of heartburn (P < 0.006), heartburn
severity area under the curve (P < 0.001), a clinical success endpoint (P <
0.001), and all other end-points (P < 0.001).
Conclusions: These data clearly demonstrate that ranitidine 75 mg is effect
ive in completely preventing or decreasing heartburn when administered 30 m
in prior to a provocative meal.