Study of LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Registration Number
- NCT00813098
- Lead Sponsor
- Lexicon Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High dose LX1031 High Dose A high dose of LX1031; daily oral intake for 28 days Low Dose LX1031 Low Dose A low dose of LX1031; daily oral intake for 28 days Placebo Placebo Matching placebo dosing with daily oral intake
- Primary Outcome Measures
Name Time Method Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4 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?"
- Secondary Outcome Measures
Name Time Method Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate Baseline to Week 4 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.
Change From Baseline at Week 4 in Stool Consistency Scores Baseline to Week 4 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.
Change From Baseline at Week 4 on the Severity of Bloating Baseline to Week 4 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.
Change From Baseline at Week 4 on the Global Improvement Score. Baseline to Week 4 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.
Change From Baseline at Week 4 in Stool Frequency Baseline to Week 4 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.
Trial Locations
- Locations (36)
Affiliated Clinical Research
🇺🇸Las Vegas, Nevada, United States
Medoff Medical/Vital re:Search
🇺🇸Greensboro, North Carolina, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
Impact Clinical Trials
🇺🇸Los Angeles, California, United States
Clinical Trials Management of Boca Raton, Inc.
🇺🇸Boca Raton, Florida, United States
Long Island Clinical Research
🇺🇸Great Neck, New York, United States
Cary Medical Research
🇺🇸Cary, North Carolina, United States
Aurora Health Center - Waukesha
🇺🇸Waukesha, Wisconsin, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
Oklahoma Foundation for Digestive Research
🇺🇸Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Utah Clinical Trials, LLC
🇺🇸Salt Lake City, Utah, United States
Arkansas Gastroenterology
🇺🇸Sherwood, Arkansas, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Genova Clinical Research
🇺🇸Tucson, Arizona, United States
Edinger Medical Group Clinical Research Center
🇺🇸Fountain Valley, California, United States
Medical Associates Research Group
🇺🇸San Diego, California, United States
Research Consultants Group
🇺🇸Hialeah, Florida, United States
Lynn Instiute of the Rockies
🇺🇸Colorado Springs, Colorado, United States
Unifour Medical Research
🇺🇸Hickory, North Carolina, United States
Gastroenterology Research Consultant of Greater Cincinnati
🇺🇸Cincinnati, Ohio, United States
Houston Medical Research Associates
🇺🇸Houston, Texas, United States
National Clinical Research Norfolk Inc.
🇺🇸Norfolk, Virginia, United States
ClinSearch
🇺🇸Chattanooga, Tennessee, United States
Northwest Clinical Trials
🇺🇸Boise, Idaho, United States
Community Clinical Trials
🇺🇸Orange, California, United States
AGMG - Orange
🇺🇸Orange, California, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Consultants for Clinical Research of S. Florida
🇺🇸Boynton Beach, Florida, United States
Accord Clinical Research, LLC
🇺🇸Port Orange, Florida, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
The UNC Center for Functional GI & Motility Disorders
🇺🇸Chapel Hill, North Carolina, United States
ActivMed Practice and Research
🇺🇸Haverhill, Massachusetts, United States
Piedmont Medical Associates
🇺🇸Winston-Salem, North Carolina, United States
Coastal Carolina Research Center in Goose Creek
🇺🇸Goose Creek, South Carolina, United States
Pioneer Research Solutions
🇺🇸Houston, Texas, United States