Irritable Bowel Syndrome
Conditions
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).
Interventions
DRUG250 mg LX1033 tablets
250 mg LX1033 tablets administered orally
DRUGPlacebo tablet
Matching placebo tablet administered orally
Sponsors
Lexicon Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in stool consistency | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in plasma 5-HIAA levels | 4 weeks |
| Change from baseline in worst abdominal pain in past 24 hours | 4 weeks |
Countries
United States
Outcome results
None listed