PANTOPRAZOLE DOES NOT AFFECT PERFORMANCE IN TRAFFIC-RELATED SAFETY TESTS - A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, CROSSOVER STUDY IN HEALTHY-VOLUNTEERS

Objective and Study Participants: The effects of pantoprazole, a poten t inhibitor of gastric acid production, were evaluated in traffic-rela ted performance tests in 18 healthy male and female volunteers, aged 1 8 to 60 years, in a randomised, placebo-controlled, double-blind, cros sover study. Methods: Oral pantoprazole (40mg) or a placebo tablet was taken once a day for two periods of 5 days each, with a washout perio d of 7 to 14 days. Drug tolerability was assessed by vital signs, clin ical 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 v isual orientation, concentration span, acoustic reaction time, multipl e choice reaction, stress, tolerance, vigilance and motor coordination . The effects were tested one day before and then on the first and fif th days of each medication period. Results: Results showed that in com parison with placebo, neither single nor multiple doses of pantoprazol e led to clinically relevant differences in the performance of standar dised, traffic-related safety tests. Conclusion: Pantoprazole did not appear to impede normal everyday activities, including car driving, an d thus can be administered without special precautions in this regard.