Clinical Trial: Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 12-Week, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study of Asimadoline in Subjects With Irritable Bowel Syndrome

Brief Summary: The purpose of this study is to evaluate the safety and efficacy of different doses of asimadoline in the treatment of patients with irritable bowel syndrome.

Detailed Summary: A randomized, dose-ranging, double-blind, placebo-controlled study designed to evaluate the efficacy and tolerability of three dose levels of asimadoline in subjects with IBS.
Sponsor: Tioga Pharmaceuticals

Current Primary Outcome: Relief of IBS Pain - total months [ Time Frame: 12 weeks ]

The primary efficacy endpoint of the study was the total number of months with adequate relief of IBS pain or discomfort.


Original Primary Outcome:

Current Secondary Outcome:

  • Relief of IBS Pain - percent of patients [ Time Frame: 12 weeks ]
    Proportion of subjects with adequate relief of IBS pain or discomfort
  • Relief of IBS Symptoms [ Time Frame: 12 weeks ]
    Adequate relief of IBS symptoms
  • Lower GI function - change from baseline [ Time Frame: 12 weeks ]
    Change from baseline in assessments of lower gastrointestinal (GI) function (i.e., stool frequency, stool consistency, urgency, bloating, and straining)
  • Abdominal Pain Score - change from baseline [ Time Frame: 12 weeks ]
    Change from baseline in abdominal pain score
  • Abdominal Discomfort Score - change from baseline [ Time Frame: 12 weeks ]
    Change from baseline in abdominal discomfort score


Original Secondary Outcome:

Information By: Tioga Pharmaceuticals

Dates:
Date Received: March 29, 2007
Date Started: August 2006
Date Completion:
Last Updated: October 17, 2011
Last Verified: October 2011