Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tioga Pharmaceuticals
With
RTI Health Solutions
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.
Age
18–79
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
