A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome
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)
2 other identifiers
interventional
373
1 country
81
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2011
CompletedFirst Posted
Study publicly available on registry
December 16, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedMarch 23, 2015
March 1, 2015
1.6 years
December 13, 2011
March 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in stool consistency
4 weeks
Secondary Outcomes (2)
Change from baseline in plasma 5-HIAA levels
4 weeks
Change from baseline in worst abdominal pain in past 24 hours
4 weeks
Study Arms (4)
Low dose
EXPERIMENTAL500 mg LX1033 two times daily
Mid dose
EXPERIMENTAL500 mg LX1033 three times daily
High dose
EXPERIMENTAL1000 mg LX1033 two times daily
Placebo
PLACEBO COMPARATORMatching placebo dosing
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (81)
Lexicon Investigational Site
Huntsville, Alabama, 35801, United States
Lexicon Investigational Site
Tempe, Arizona, 85282, United States
Lexicon Investigational Site
Tucson, Arizona, 85704, United States
Lexicon Investigational Site
Tucson, Arizona, 85712, United States
Lexicon Investigational Site
Little Rock, Arkansas, 72211, United States
Lexicon Investigational Site
North Little Rock, Arkansas, 72117, United States
Lexicon Investigational Site
Anaheim, California, 92801, United States
Lexicon Investigational Site
Encinitas, California, 92024, United States
Lexicon Investigational Site
Los Angeles, California, 90095, United States
Lexicon Investigational Site
Oakland, California, 94609, United States
Lexicon Investigational Site
Orange, California, 92868, United States
Lexicon Investigational Site
San Diego, California, 92108, United States
Lexicon Investigational Site
Santa Monica, California, 90404, United States
Lexicon Investigational Site
Tustin, California, 92780, United States
Lexicon Investigational Site
Westlake Village, California, 91361, United States
Lexicon Investigational Site
Littleton, Colorado, 80120, United States
Lexicon Investigational Site
Littleton, Colorado, 80128, United States
Lexicon Investigational Site
Wheat Ridge, Colorado, 80033, United States
Lexicon Investigational Site
Waterbury, Connecticut, 06708, United States
Lexicon Investigational Site
Boynton Beach, Florida, 33426, United States
Lexicon Investigational Site
Bradenton, Florida, 34208, United States
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Brooksville, Florida, 34601, United States
Lexicon Investigational Site
DeLand, Florida, 32720, United States
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Jacksonville, Florida, 32256, United States
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Kissimmee, Florida, 34741, United States
Lexicon Investigational Site
Lauderdale Lakes, Florida, 33319, United States
Lexicon Investigational Site
Maitland, Florida, 32751, United States
Lexicon Investigational Site
Orlando, Florida, 32806, United States
Lexicon Investigational Site
Port Orange, Florida, 32129, United States
Lexicon Investigational Site
Tampa, Florida, 33606, United States
Lexicon Investigational Site
Boise, Idaho, 83704, United States
Lexicon Investigational Site
Meridian, Idaho, 83642, United States
Lexicon Investigational Site
Addison, Illinois, 60101, United States
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Chicago, Illinois, 60622, United States
Lexicon Investigational Site
Rockford, Illinois, 61107, United States
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Wichita, Kansas, 67207, United States
Lexicon Investigational Site
Bowling Green, Kentucky, 42101, United States
Lexicon Investigational Site
Lexington, Kentucky, 40504, United States
Lexicon Investigational Site
Chevy Chase, Maryland, 20815, United States
Lexicon Investigational Site
Towson, Maryland, 21204, United States
Lexicon Investigational Site
Brockton, Massachusetts, 02301, United States
Lexicon Investigational Site
Chesterfield, Michigan, 48047, United States
Lexicon Investigational Site
Kalamazoo, Michigan, 49009, United States
Lexicon Investigational Site
Troy, Michigan, 48098, United States
Lexicon Investigational Site
Jackson, Mississippi, 39202, United States
Lexicon Investigational Site
Mexico, Missouri, 65265, United States
Lexicon Investigational Site
Billings, Montana, 59102, United States
Lexicon Investigational Site
Berlin, New Jersey, 08009, United States
Lexicon Investigational Site
Albuquerque, New Mexico, 87102, United States
Lexicon Investigational Site
Great Neck, New York, 11021, United States
Lexicon Investigational Site
Great Neck, New York, 11023, United States
Lexicon Investigational Site
New York, New York, 10022, United States
Lexicon Investigational Site
Boone, North Carolina, 28607, United States
Lexicon Investigational Site
Cary, North Carolina, 27518, United States
Lexicon Investigational Site
Chapel Hill, North Carolina, 27599, United States
Lexicon Investigational Site
Greensboro, North Carolina, 27408, United States
Lexicon Investigational Site
High Point, North Carolina, 27262, United States
Lexicon Investigational Site
Raleigh, North Carolina, 27612, United States
Lexicon Investigational Site
Winston-Salem, North Carolina, 27103, United States
Lexicon Investigational Site
Fargo, North Dakota, 58103, United States
Lexicon Investigational Site
Kettering, Ohio, 45429, United States
Lexicon Investigational Site
Lima, Ohio, 45806, United States
Lexicon Investigational Site
Mentor, Ohio, 44060, United States
Lexicon Investigational Site
Wadsworth, Ohio, 44281, United States
Lexicon Investigational Site
Norman, Oklahoma, 73069, United States
Lexicon Investigational Site
Oklahoma City, Oklahoma, 73104, United States
Lexicon Investigational Site
Eugene, Oregon, 97404, United States
Lexicon Investigational Site
Mt. Pleasant, South Carolina, 29464, United States
Lexicon Investigational Site
Chattanooga, Tennessee, 37421, United States
Lexicon Investigational Site
Austin, Texas, 78756, United States
Lexicon Investigational Site
El Paso, Texas, 79902, United States
Lexicon Investigational Site
Lake Jackson, Texas, 77566, United States
Lexicon Investigational Site
Plano, Texas, 75075, United States
Lexicon Investigational Site
San Antonio, Texas, 78229, United States
Lexicon Investigational Site
Clinton, Utah, 84105, United States
Lexicon Investigational Site
Logan, Utah, 84341, United States
Lexicon Investigational Site
Ogden, Utah, 84405, United States
Lexicon Investigational Site
Sandy City, Utah, 84904, United States
Lexicon Investigational Site
West Jordan, Utah, 84088, United States
Lexicon Investigational Site
Lynchburg, Virginia, 24502, United States
Lexicon Investigational Site
Virginia Beach, Virginia, 23454, United States
Related Publications (1)
Delgado-Herrera L, Lasch K, Zeiher B, Lembo AJ, Drossman DA, Banderas B, Rosa K, Lademacher C, Arbuckle R. Evaluation and performance of a newly developed patient-reported outcome instrument for diarrhea-predominant irritable bowel syndrome in a clinical study population. Therap Adv Gastroenterol. 2017 Sep;10(9):673-687. doi: 10.1177/1756283X17726018. Epub 2017 Aug 24.
PMID: 28932269DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sumen Wason, MD
Lexicon Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2011
First Posted
December 16, 2011
Study Start
February 1, 2012
Primary Completion
September 1, 2013
Last Updated
March 23, 2015
Record last verified: 2015-03