Irritable Bowel Syndrome
Conditions
Keywords
Irritable Bowel Syndrome, Asimadoline
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 description
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.
Interventions
DRUGAsimadoline
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
DRUGPlacebo
Placebo was provided in coated tablets identical in appearance to asimadoline tablets.
Sponsors
RTI Health Solutions
Tioga Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relief of IBS Pain - total months | 12 weeks | The primary efficacy endpoint of the study was the total number of months with adequate relief of IBS pain or discomfort. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lower GI function - change from baseline | 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 | 12 weeks | Change from baseline in abdominal pain score |
| Relief of IBS Pain - percent of patients | 12 weeks | Proportion of subjects with adequate relief of IBS pain or discomfort |
| Relief of IBS Symptoms | 12 weeks | Adequate relief of IBS symptoms |
| Abdominal Discomfort Score - change from baseline | 12 weeks | Change from baseline in abdominal discomfort score |
Countries
United States
Outcome results
None listed