Status:
COMPLETED
A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome
Lead Sponsor:
Lexicon Pharmaceuticals
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
373 Patients enrolled
Trial Details
Trial ID
NCT01494233
Start Date
February 1 2012
Last Update
March 23 2015
Active Locations (81)
Enter a location and click search to find clinical trials sorted by distance.
1
Lexicon Investigational Site
Huntsville, Alabama, United States, 35801
2
Lexicon Investigational Site
Tempe, Arizona, United States, 85282
3
Lexicon Investigational Site
Tucson, Arizona, United States, 85704
4
Lexicon Investigational Site
Tucson, Arizona, United States, 85712