A DOUBLE-BLIND-STUDY OF PANTOPRAZOLE AND RANITIDINE IN TREATMENT OF ACUTE DUODENAL-ULCER - A MULTICENTER TRIAL

Pantoprazole is a new substituted benzimidazole, which is a potent inh ibitor of gastric acid secretion by its inhibition of H+,K+-ATPase. Pa ntoprazole, 40 mg, was compared with the H-2-receptor antagonist ranit idine, 300 mg, in the healing of acute duodenal ulcer. Two hundred sev enty-six patients with endoscopically diagnosed duodenal ulcer were st udied in this multicenter double-blind study. Patients were reendoscop ied after two weeks of treatment, and those patients whose ulcers rema ined unhealed were also endoscoped after an additional two weeks of tr eatment. The primary end point was the complete healing of the ulcer. Demographic characteristics were comparable in both treatment groups, After two weeks of treatment, 90/124 (73%) patients in the pantoprazol e group had healed ulcers compared with 57/126 (45%) patients in the r anitidine group (P < 0.001, per-protocol analysis). After four weeks, the cumulative healing rates were 92% and 84% in the pantoprazole and ranitidine groups, respectively (P = 0.073). Symptoms were also improv ed at week 2, with 84% and 72% of patients in the pantoprazole and ran itidine groups, respectively, reporting no ulcer pain (P < 0.05, per-p rotocol analysis). Both treatments were well tolerated, This study has confirmed the superiority of pantoprazole compared with ranitidine in the healing of duodenal ulcers and pain relief after two weeks of tre atment and has shown pantoprazole to be well tolerated in this indicat ion.