A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of Asimadoline in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS)
A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of Asimadoline in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS)
The purpose of this study is to determine whether asimadoline is safe and effective at treating D-IBS.
The primary objective of the study is to compare the efficacy of the two treatments with respect to improvement in IBS-related abdominal pain severity and reduction in stool frequency. During the 12-week treatment period, daily IBS-related abdominal pain severity score and daily frequency of bowel movements will be averaged over each week to determine average values for each endpoint. For each subject, weekly response to treatment will be based on the following parameters:
Inclusion Criteria:
Signs and dates a written informed consent form.
Male and female subjects aged 18-79 who are fluent in English
All subjects must use protocol specified contraceptive measures
The subject is or has been diagnosed with IBS with symptom onset at least 6 months prior to diagnosis. IBS is defined as the subject having recurrent abdominal pain or discomfort at least 3 days per month in the past 3 months associated with at least two of the following symptoms:
Improvement with defecation Onset associated with a change in frequency of stool Onset associated with a change in form (appearance) of stool
The subject has been diagnosed with diarrhea-predominant IBS
Within 2 years of the randomization visit, the subject has normal results from a flexible sigmoidoscopy, a colonoscopy, or a barium enema plus flexible sigmoidoscopy, according to the subject's age by a specified algorithm.
Exclusion Criteria:
Brookville, Florida 34601, United States
Lees Summit, Missouri 64064, United States
Chapel Hill, North Carolina 27599, United States