A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome
Status: | Recruiting |
---|---|
Conditions: | Irritable Bowel Syndrome (IBS) |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 11/30/-0001 |
Start Date: | February 2012 |
Contact: | Luke Lawson, Project Manager |
Phone: | 281-863-3146 |
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Safety and Efficacy of Orally Administered LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
The objective of this study is to evaluate the safety and efficacy of LX1033 over a range of
dose levels in subjects with diarrhea-predominant Irritable Bowel Syndrome (IBS).
Inclusion Criteria:
- Male and female subjects, aged 18 to 70 years, with diarrhea-predominant IBS (IBS-D)
with symptom onset at least 6 months prior to diagnosis
- Two or more days per week with at least one stool with a consistency of Type 6 or 7
(Bristol Stool Form Scale)
- Weekly average of worst abdominal pain in past 24 hours score of greater than or
equal to 3.0 using a 0-10 point scale
- Ability to provide written, informed consent
Exclusion Criteria:
- Inability to discontinue any current drug therapy for IBS, with the exception of
bulking agents. Subjects will be allowed up to 2 doses of loperamide per week as
rescue medication.
- Subjects who score severe abdominal pain (rated 7 or higher) 5 or more days per week
- Concomitant use of opioid analgesic drugs or drugs that affect bowel motility
- Any abnormalities or conditions deemed by the investigator as clinically significant
We found this trial at
30
sites
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