Status:
COMPLETED
Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome
Lead Sponsor:
Tioga Pharmaceuticals
Collaborating Sponsors:
RTI Health Solutions
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
596 Patients enrolled
Trial Details
Trial ID
NCT00454688
Start Date
August 1 2006
End Date
December 1 2007
Last Update
October 18 2011
Active Locations (112)
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1
Medical Affiliated Research Center
Huntsville, Alabama, United States, 35801
2
Lovelace Scientific Resources
Pheonix, Arizona, United States, 85016
3
Lovelace Scientific Resources
Phoenix, Arizona, United States, 85016
4
Redpoint Research
Phoenix, Arizona, United States, 85029