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 ]
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