DOUBLE-BLIND RANDOMIZED, MULTICENTER STUDY COMPARING ALUMINUM PHOSPHATE GEL WITH RANITIDINE IN THE SHORT-TERM TREATMENT OF DUODENAL-ULCER

The efficacy and safety of aluminium phosphate and ranitidine in the s hort-term treatment of duodenal ulcer were compared in a multicenter, randomized, double-blind study. A total of 304 patients with endoscopi cally proven active duodenal ulcer were recruited: 153 received 11 g o f aluminum phosphate gel five times a day (equivalent to a daily acid buffering capacity of 182 mEq/HC1) and 151 rantitidine 300 mg once dai ly for 6 weeks. At the end of the treatment period, 74 out of 113 pati ents (65 %) treated with aluminium phosphate and 84 out of 105 patient s (80 %) treated with rantitidine showed ulcer healing at endoscopy (p = 0.02). Ulcer symptoms, identified as frequency and intensity of day time and nocturnal epigastric pain, were significantly reduced by both treatments, but rantitidine proved more effective than aluminium phos phate in reducing the frequency of daytime pain (p < 0.01) and its sev erity (p < 0.01); In contrast, no significant differences were found w ith regard to frequency and severity of nocturnal pain. The incidence of unwanted effects was significantly higher in the aluminium phosphat e group. The main adverse event observed was constipation which, howev er, was hardly ever severe enough to warrent discontinuing treatment.