Study of LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX1031 versus a placebo control in subjects with non-constipating irritable bowel syndrome.

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 LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: LX1031 High Dose
* Drug: LX1031 Low Dose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females aged 18-70 years old Documented diagnosis of IBS (IBS-diarrhea or IBS-mixed) based upon Rome III criteria Abdominal pain/discomfort at least 2 days per week during the screening and run-in periods Normal structural evaluation of the colon within 5 years prior to screening Ability to provide written informed consent Exclusion Criteria: Inability to discontinue current drug therapy for IBS, except for bulking agents, through the duration of the study Use of anticholinergic antidepressants, opioid pain medications, or any drugs that affect bowel motility Lactose intolerance Major psychological disorder Significant nicotine or caffeine use (>10 cigarettes and/or six 8 ounce cups of coffee per day, respectively)

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose<br>A high dose of LX1031; daily oral intake for 28 days | Drug: LX1031 High Dose<br>* A high dose of LX1031; daily oral intake for 28 days<br>|
| Experimental: Low Dose<br>A low dose of LX1031; daily oral intake for 28 days | Drug: LX1031 Low Dose<br>* A low dose of LX1031; daily oral intake for 28 days.<br>|
| Placebo Comparator: Placebo<br>Matching placebo dosing with daily oral intake | Drug: Placebo<br>* Matching placebo dosing with daily oral intake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4 | The primary efficacy endpoint was the proportion of subjects experiencing relief of IBS pain and discomfort at Week 4 as measured by the response to the question,In the past 7 days have you had adequate relief of your irritable bowel syndrome pain and discomfort? | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate | To assess sensation of urgency to defecate on a daily basis, subjects recorded in their daily diary a response to the following question,Have you felt or experienced a sense of urgency to pass stool today? The mean score (proportion of days per week when the subject experienced an urge to defecate) for Week 4 was subtracted from the baseline mean score to determine the mean change from baseline. | Baseline to Week 4 | 
| Change From Baseline at Week 4 in Stool Consistency Scores | Stool consistency was evaluated using the 7-point Bristol Stool Scale in which a score of 1 indicates separate hard lumps, 2 indicates sausage shaped but lumpy, 3 indicates sausage-like with cracks on the surface, 4 indicates sausage-like but smooth and soft, 5 indicates soft blobs with clear cut edges, 6 indicates fluffy pieces with ragged edges, and 7 indicates watery with no solid pieces. The mean score for Week 4 was subtracted from the baseline mean score to obtain the mean change from baseline. | Baseline to Week 4 | 
| Change From Baseline at Week 4 in Stool Frequency | Subjects recorded the number of times they passed stool on a daily basis in the daily diary. The mean for Week 4 was subtracted from the baseline mean to obtain the mean change from baseline in stool frequency. | Baseline to Week 4 | 
| Change From Baseline at Week 4 on the Severity of Bloating | Subjects recorded in the daily diary the level of bloating they felt on a daily basis using a 100 mm visual analog scale (with 0 being not at all and 100 mm being worst possible). The mean score for Week 4 was subtracted from the baseline mean score to obtain the mean change from baseline in severity of bloating. | Baseline to Week 4 | 
| Change From Baseline at Week 4 on the Global Improvement Score. | The IBS Global Improvement Scale (IBS-GAI) asks Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been: 1-substantially worse, 2-moderately worse, 3-slightly worse, 4-no change, 5-slightly improved, 6-moderately improved, 7-substantially improved? The mean score for Week 4 was subtracted from the mean baseline score to obtain the mean change from baseline on the Global Improvement Score. | Baseline to Week 4 |