| Study summary: |
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A phase2, 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). |
| Qualified participants must: |
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• Be 18-70 years of age
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Be diagnosed with diarrhea predominant IBS based upon criteria, as follows: Recurrent abdominal pain or discomfort, defined as an uncomfortable sensation not described as pain, at least 3 days/month during the last 3 months associated with two or more of the following characteristics:
1. Improvement with defecation.
2. Onset associated with a change in frequency of stool (i.e. increased).
3. Onset associated with a change in form (appearance) of stool (i.e. loose/watery).
4. Two or more days per week with at least one stool which has a consistency of Type 6 or 7 (BSS) for each of the two weeks during the two-week Run-in period
5. Weekly average of worst abdominal pain in past 24 hours score of > 3.0 using a 0-10 point scale, for each of the two weeks during the two-week Run-in period.
6. Normal structural evaluation of the colon (by air contrast barium enema, virtual colonoscopy or endoscopic colonoscopy) within 5 years prior to Screening for subjects >50 years or subjects who have alarm features (e.g., anemia, clinically significant weight loss that’s not intended, family history of colorectal cancer, rectal bleeding, etc).
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| Participants may receive: |
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Compensation for time and travel. |