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: * Decrease from baseline of at least 30% in the average IBS-related daily abdominal pain severity score * Decrease from baseline of at least 25% in the average number of daily bowel movements A subject must meet both criteria to be considered a weekly responder. The primary efficacy endpoint is based on an "overall study responder," defined as a subject having 6 or more weeks of weekly response to treatment out of the 12 weeks in the treatment period. Overall study responder will be stratified by timing of bowel preparation and endoscopy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
611
0.5 mg Asimadoline BID
Placebo
12 Week Abdominal Pain and Stool (APS) Frequency Responder
A study responder is a subject who has both a decrease from baseline of IBS-related abdominal pain and a decrease from baseline of daily bowel movements
Time frame: Weekly responder based on patient assessments made daily in each week of the 12-week Treatment Period to determine 12 week APS responder
Compare the two treatment groups with respect to IBS-related abdominal pain
Time frame: Up to 12 weeks
Compare the two treatment groups with respect to stool frequency
Time frame: Up to 12 weeks
Compare the two treatment groups with respect to stool urgency
Time frame: Up to 12 weeks
Compare the two treatment groups with respect to IBS symptoms
Time frame: up to 12 weeks
Compare the two treatment groups with respect to stool consistency scores
Using the Bristol Stool Form Scale
Time frame: Up to 12 weeks
Incidence of adverse events as a measure of tolerability
Time frame: Up to 16 weeks
Abnormalities of laboratory tests as a measure of tolerability
Time frame: Up to 16 weeks
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