A dose-ranging, placebo-controlled, randomized trial of alosetron in patients with functional dyspepsia

Background: Functional dyspepsia is characterized by upper abdominal pain o r discomfort. Aim: To assess the benefit of the 5-HT3-receptor antagonist alosetron in a pilot, dose-ranging, placebo-controlled, multicentre, randomized clinical t rial. Methods: A total of 320 functional dyspepsia patients received placebo (n = 81), or alosetron 0.5 mg b.d. (n = 77), 1.0 mg b.d. (n = 79) or 2.0 mg b.d . (n = 83) for 12 weeks, followed by 1 week of follow-up. Primary efficacy was the 12-week average rate of adequate relief of upper abdominal pain or discomfort. Secondary endpoints assessed pain and upper gastrointestinal sy mptoms. Results: Twelve-week average rates of adequate relief of pain or discomfort were 46% (95% CI: 37-54%), 55% (95% CI: 46-63%), 55% (95% CI: 47-64%) and 47% (95% CI: 38-55%) in the placebo, 0.5 mg, 1.0 mg and 2.0 mg alosetron gr oups, respectively. Alosetron 0.5 mg or 1.0 mg showed potential benefit ove r placebo for early satiety and postprandial fullness. Females showed great er responses compared to males, Patients with adequate relief had significa ntly (P < 0.001) greater reductions in severity and frequency of functional dyspepsia symptoms than those without adequate relief. Constipation was th e most commonly reported adverse event. Conclusions: Alosetron showed potential benefit in relieving functional dys pepsia symptoms compared to placebo. Patients with adequate relief of upper abdominal pain or discomfort showed improvements in multiple functional dy spepsia symptoms.