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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
155
A high dose of LX1031; daily oral intake for 28 days
A low dose of LX1031; daily oral intake for 28 days.
Matching placebo dosing with daily oral intake
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?"
Time frame: Week 4
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 4
Change From Baseline at Week 4 on the Severity of Bloating
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Genova Clinical Research
Tucson, Arizona, United States
Arkansas Gastroenterology
Sherwood, Arkansas, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Edinger Medical Group Clinical Research Center
Fountain Valley, California, United States
Impact Clinical Trials
Los Angeles, California, United States
Community Clinical Trials
Orange, California, United States
AGMG - Orange
Orange, California, United States
Medical Associates Research Group
San Diego, California, United States
Lynn Instiute of the Rockies
Colorado Springs, Colorado, United States
Clinical Trials Management of Boca Raton, Inc.
Boca Raton, Florida, United States
...and 26 more locations
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.
Time frame: 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.
Time frame: Baseline to Week 4