A Dose-Ranging, Phase II Study of the Efficacy and Safety of Alosetron in Men with Diarrhea-Predominant IBS

• DOI: 10.1111/j.1572-0241.2005.40365.x
• Publication Date: 2005-01-04T15:16:50Z
• Authors: Lin Chang; Vanessa Z. Ameen; George E. Dukes; David J. McSorley; Eric G. Carter; Emeran A. Mayer
• Keywords: Bloating; Dose-ranging study; Clinical endpoint

BACKGROUND A randomized, double blind, placebo-controlled dose-ranging study was conducted to assess the efficacy of alosetron in men with diarrhea-predominant irritable bowel syndrome (IBS). METHODS Six hundred and sixty-two were randomized treatment 0.5, 1.0, 2.0, 4.0 mg, or placebo twice daily for 12 wk, followed by a 4-wk posttreatment period. Adequate relief IBS pain discomfort during week 5–12 phase primary endpoint; secondary endpoints included urgency, stool frequency, consistency, incomplete evacuation, bloating, abdominal discomfort. RESULTS Subjects ranked urgency as their most bothersome symptoms. The average rate adequate significantly higher 1.0 mg twice-daily group compared (53% vs 40%, p = 0.04), all doses reduced consistency scores (p < 0.001) indicating firmer stools. No significant effects seen regard number movements, evacuation. Constipation common adverse event occurred dose-related manner among subjects receiving alosetron, 9% (0.5 daily), 15% (1.0 11% (2.0 21% (4.0 daily). serious events constipation reported. One subject 0.5 had an episode rectal bleeding suggestive possible diagnosis ischemic colitis. CONCLUSIONS Alosetron 1 provided discomfort, improved IBS.