Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome
A 12-Week, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study of Asimadoline in Subjects With Irritable Bowel Syndrome
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.
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.
Asimadoline was provided in coated tablets of three dosages (0.15 mg, 0.5 mg, and 1.0 mg). All asimadoline tablets used in this trial were synthesized from the same batch of drug substance (Batch EF418492). Asimadoline was administered orally, BID for 12 weeks
Placebo was provided in coated tablets identical in appearance to asimadoline tablets.
Inclusion Criteria: Males and females aged 18-79 Must sign an ICF Females of childbearing potential must have a negative pregnancy test at screening and must adhere to contraception throughout the trial Must have been diagnosed with IBS as a result of having at least 6 months, not necessarily consecutive, in the preceding 12 months of recurrent symptoms of abdominal discomfort or pain associated with at least 2 of the following: 1)relieved with defecation; 2)onset associated with a change in stool frequency; 3)onset associated with a change in stool form Must demonstrate a willingness to comply with daily telephone diary entry Exclusion Criteria: Any subject with evidence of a biochemical or structural abnormality of the digestive tract or other co-morbid illness that might impact the ability to interpret the safety and efficacy data Pregnant or breastfeeding females Refusal to discontinue prohibited concomitant medications Use of an investigational drug or participation in an investigational study within 30 days of screening Inability or unwillingness to use the touch-tone telephone data entry system