A Phase 2 interventional study of 250 mg LX1033 tablets and Placebo tablet in Irritable Bowel Syndrome, sponsored by Lexicon Pharmaceuticals. Completed at 81 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-03-23.
Sponsored by Lexicon Pharmaceuticals · Phase 2, Interventional, and Treatment
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).
1,084 studies on the registry are indexed under Irritable Bowel Syndrome; 196 are open to participants now.
This study's enrollment of 373 is above the median of 70 across 869 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Lexicon Pharmaceuticals is the lead sponsor of 61 studies on the registry; none are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 15 (83%) have results posted.
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Exclusion Criteria:
500 mg LX1033 two times daily
Drug: 250 mg LX1033 tablets
500 mg LX1033 three times daily
Drug: 250 mg LX1033 tablets
1000 mg LX1033 two times daily
Drug: 250 mg LX1033 tablets
Matching placebo dosing
Drug: Placebo tablet
250 mg LX1033 tablets administered orally
Matching placebo tablet administered orally
Change from baseline in stool consistency
Time frame: 4 weeks
Change from baseline in plasma 5-HIAA levels
Time frame: 4 weeks
Change from baseline in worst abdominal pain in past 24 hours
Time frame: 4 weeks
The record gives a start of Feb 2012 and a primary completion of Sep 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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