Methods: In this randomized, double-blind, multicentre study, the proton pump inhibitors pantoprazole and omeprazole were compared in patients with active duodenal ulcers. Two hundred and seventy-six protocol-correct patients received either pantoprazole 40 mg (n = 185) or omeprazole 20 mg (n = 91), once daily for 2 or 4 weeks, depending on the progress of ulcer healing.
Results: Rates of complete ulcer healing after 2 weeks were 71% in patients given pantoprazole and 74% in patients given omeprazole. After 4 weeks the figures were 96% and 91%, respectively. These differences were not significant. There was no significant difference in ulcer pain prior to treatment, and 85% of the pantoprazole group and 86% on omeprazole were pain-free after 2 weeks (not significant). The time until complete pain relief with pantoprazole or omeprazole, based on data from diary cards, was not significantly different (P > 0.05, Uleman's U-test). Both treatments were equally well tolerated. Changes in routine laboratory parameters were minimal in both groups.
Conclusion: Pantoprazole was shown to be a highly-effective and well-tolerated treatment for acute duodenal ulcer. Pantoprazole 40 mg and omeprazole 20 mg were equally effective with respect to ulcer healing and pain relief, and have similar adverse event profiles.