Double-blind Comparison of Pantoprazole and Omeprazole for the Treatment of Acute Duodenal Ulcer

Eur J Gastroenterol Hepatol. 1995 May;7(5):407-10.

Abstract

Objectives: To compare the healing rates of acute duodenal ulcer in patients receiving pantoprazole 40 mg or omeprazole 20 mg once daily and to assess drug tolerance.

Design: Randomized, double-blind study evaluating patients with healed duodenal ulcer on endoscopy after 2 weeks of treatment and patients unhealed at 2 and after 4 weeks of treatment.

Setting: Hospital or private gastroenterology practice outpatients.

Patients: Men or women, aged at least 18 years, with one or two duodenal ulcers. Patients with ulcer complications or with other significant acid-related disease were excluded. A total of 270 patients entered the study, of whom 255 were included in the per-protocol analysis.

Results: The primary measure of efficacy was the healing rates of duodenal ulcers. Complete healing of ulcers was observed in 88 (71%) of the 124 patients in the pantoprazole group and in 85 (65%) of the 131 patients in the omeprazole group after 2 weeks of treatment. The cumulative healing rates after 4 weeks were 118 (95%) out of 124 and 117 (89%) out of 131 patients, respectively. There was no significant difference between treatment groups with respect to either healing rates or freedom from ulcer pain at 2 weeks. Both treatments were well tolerated: only 10 and 11 patients in the pantoprazole and omeprazole groups, respectively, reported adverse events. Diarrhoea was reported by two patients in each group.

Conclusions: Pantoprazole 40 mg daily and omeprazole 20 mg daily are equally effective in inducing ulcer healing.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Acute Disease
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Ulcer Agents / administration & dosage
  • Anti-Ulcer Agents / adverse effects
  • Anti-Ulcer Agents / therapeutic use*
  • Benzimidazoles / administration & dosage
  • Benzimidazoles / adverse effects
  • Benzimidazoles / therapeutic use*
  • Diarrhea / chemically induced
  • Double-Blind Method
  • Drug Tolerance
  • Duodenal Ulcer / drug therapy*
  • Duodenoscopy
  • Female
  • Humans
  • Male
  • Middle Aged
  • Omeprazole / administration & dosage
  • Omeprazole / adverse effects
  • Omeprazole / therapeutic use*
  • Pantoprazole
  • Sulfoxides / administration & dosage
  • Sulfoxides / adverse effects
  • Sulfoxides / therapeutic use*
  • Wound Healing

Substances

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Anti-Ulcer Agents
  • Benzimidazoles
  • Sulfoxides
  • Pantoprazole
  • Omeprazole