Status:
COMPLETED
Study of LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome
Lead Sponsor:
Lexicon Pharmaceuticals
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX1031 versus a placebo control in subjects with non-constipating irritable bowel syndrome.
Eligibility Criteria
Inclusion
- Males and females aged 18-70 years old
- Documented diagnosis of IBS (IBS-diarrhea or IBS-mixed) based upon Rome III criteria
- Abdominal pain/discomfort at least 2 days per week during the screening and run-in periods
- Normal structural evaluation of the colon within 5 years prior to screening
- Ability to provide written informed consent
Exclusion
- Inability to discontinue current drug therapy for IBS, except for bulking agents, through the duration of the study
- Use of anticholinergic antidepressants, opioid pain medications, or any drugs that affect bowel motility
- Lactose intolerance
- Major psychological disorder
- Significant nicotine or caffeine use (\>10 cigarettes and/or six 8 ounce cups of coffee per day, respectively)
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00813098
Start Date
December 1 2008
End Date
August 1 2010
Last Update
December 2 2010
Active Locations (36)
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1
Genova Clinical Research
Tucson, Arizona, United States, 85741
2
Arkansas Gastroenterology
Sherwood, Arkansas, United States, 72120
3
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
4
Edinger Medical Group Clinical Research Center
Fountain Valley, California, United States, 92708