Abstract
test and comparison to placebo by Wilcoxon Rank Sum test. Results. In the placebo group reflux episodes increased from D-1 to D6. This effect was reduced in the ADX10059 treatment groups. A significant treatment effect was seen for total acid exposure % (p=0.048) and number of weakly acidic reflux episodes (p = 0.0411). Significant differences from placebo were seen for 125mg b.i.d for various reflux measures. Trends were also seen for the 250mg b.i.d. dose which did not appear more effective than 125mg b.i.d. The 50mg b.i.d dose was not significantly superior to placebo. Twice daily administration of ADX10059 gave satisfactory 24 hour plasma concentrations. All 3 doses were well tolerated. Adverse event frequency was 50 mg : n=3 ; 125 mg : n=8 ; 250 mg : n=9. All were mild or moderate. Themost commonwere insomnia (n=4), constipation (n=2) and flatulence (n=2). Conclusion. Compared to placebo, ADX10059 dose dependently decreased gastro-esophageal reflux events in healthy subjects. The tolerability of the MR formulation is suitable for longer term treatment to evaluate clinical symptom control in GERD patients. Median and 95% CI of changes Day -1 to Day 6 for 5 hour pH-impedance monitoring period
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