A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: 250 mg LX1033 tablets
* Drug: Placebo tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose<br>500 mg LX1033 two times daily | Drug: 250 mg LX1033 tablets<br>* 250 mg LX1033 tablets administered orally<br>|
| Experimental: Mid dose<br>500 mg LX1033 three times daily | Drug: 250 mg LX1033 tablets<br>* 250 mg LX1033 tablets administered orally<br>|
| Experimental: High dose<br>1000 mg LX1033 two times daily | Drug: 250 mg LX1033 tablets<br>* 250 mg LX1033 tablets administered orally<br>|
| Placebo Comparator: Placebo<br>Matching placebo dosing | Drug: Placebo tablet<br>* Matching placebo tablet administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in stool consistency |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |