Pantoprazole does not affect performance in traffic-related safety tests: a double-blind, randomised, placebo-controlled, crossover study in healthy volunteers

• Published in: Clinical drug investigation 1998, Vol.16 (1), p.63-70
• Main Authors: Herberg, K W, Hartmann, M, Neukirchen, B, Lühmann, R, Thomas, K B, Wurst, W
• Format: Article
• Language: English
• ISSN: 1173-2563
• DOI: 10.2165/00044011-199816010-00008

OBJECTIVE AND STUDY PARTICIPANTS: The effects of pantoprazole, a potent inhibitor of gastric acid production, were evaluated in traffic-related performance tests in 18 healthy male and female volunteers, aged 18 to 60 years, in a randomised, placebo-controlled, double-blind, crossover study. Oral pantoprazole (40mg) or a placebo tablet was taken once a day for two periods of 5 days each, with a washout period of 7 to 14 days. Drug tolerability was assessed by vital signs, clinical laboratory parameters and volunteers' own subjective appraisal of their mental condition. The computerised Viennese test system (WTS 90) was used to examine parameters related to traffic safety including visual orientation, concentration span, acoustic reaction time, multiple choice reaction, stress, tolerance, vigilance and motor coordination. The effects were tested one day before and then on the first and fifth days of each medication period. Results showed that in comparison with placebo, neither single nor multiple doses of pantoprazole led to clinically relevant differences in the performance of standardised, traffic-related safety tests. Pantoprazole did not appear to impede normal everyday activities, including car driving, and thus can be administered without special precautions in this regard.