A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome
NCT ID: NCT01494233
Last Updated: 2015-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
373 participants
INTERVENTIONAL
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low dose
500 mg LX1033 two times daily
250 mg LX1033 tablets
250 mg LX1033 tablets administered orally
Mid dose
500 mg LX1033 three times daily
250 mg LX1033 tablets
250 mg LX1033 tablets administered orally
High dose
1000 mg LX1033 two times daily
250 mg LX1033 tablets
250 mg LX1033 tablets administered orally
Placebo
Matching placebo dosing
Placebo tablet
Matching placebo tablet administered orally
Interventions
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250 mg LX1033 tablets
250 mg LX1033 tablets administered orally
Placebo tablet
Matching placebo tablet administered orally
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Sumen Wason, MD
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals, Inc.
Locations
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Lexicon Investigational Site
Huntsville, Alabama, United States
Lexicon Investigational Site
Tempe, Arizona, United States
Lexicon Investigational Site
Tucson, Arizona, United States
Lexicon Investigational Site
Tucson, Arizona, United States
Lexicon Investigational Site
Little Rock, Arkansas, United States
Lexicon Investigational Site
North Little Rock, Arkansas, United States
Lexicon Investigational Site
Anaheim, California, United States
Lexicon Investigational Site
Encinitas, California, United States
Lexicon Investigational Site
Los Angeles, California, United States
Lexicon Investigational Site
Oakland, California, United States
Lexicon Investigational Site
Orange, California, United States
Lexicon Investigational Site
San Diego, California, United States
Lexicon Investigational Site
Santa Monica, California, United States
Lexicon Investigational Site
Tustin, California, United States
Lexicon Investigational Site
Westlake Village, California, United States
Lexicon Investigational Site
Littleton, Colorado, United States
Lexicon Investigational Site
Littleton, Colorado, United States
Lexicon Investigational Site
Wheat Ridge, Colorado, United States
Lexicon Investigational Site
Waterbury, Connecticut, United States
Lexicon Investigational Site
Boynton Beach, Florida, United States
Lexicon Investigational Site
Bradenton, Florida, United States
Lexicon Investigational Site
Brooksville, Florida, United States
Lexicon Investigational Site
DeLand, Florida, United States
Lexicon Investigational Site
Jacksonville, Florida, United States
Lexicon Investigational Site
Kissimmee, Florida, United States
Lexicon Investigational Site
Lauderdale Lakes, Florida, United States
Lexicon Investigational Site
Maitland, Florida, United States
Lexicon Investigational Site
Orlando, Florida, United States
Lexicon Investigational Site
Port Orange, Florida, United States
Lexicon Investigational Site
Tampa, Florida, United States
Lexicon Investigational Site
Boise, Idaho, United States
Lexicon Investigational Site
Meridian, Idaho, United States
Lexicon Investigational Site
Addison, Illinois, United States
Lexicon Investigational Site
Chicago, Illinois, United States
Lexicon Investigational Site
Rockford, Illinois, United States
Lexicon Investigational Site
Wichita, Kansas, United States
Lexicon Investigational Site
Bowling Green, Kentucky, United States
Lexicon Investigational Site
Lexington, Kentucky, United States
Lexicon Investigational Site
Chevy Chase, Maryland, United States
Lexicon Investigational Site
Towson, Maryland, United States
Lexicon Investigational Site
Brockton, Massachusetts, United States
Lexicon Investigational Site
Chesterfield, Michigan, United States
Lexicon Investigational Site
Kalamazoo, Michigan, United States
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Troy, Michigan, United States
Lexicon Investigational Site
Jackson, Mississippi, United States
Lexicon Investigational Site
Mexico, Missouri, United States
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Billings, Montana, United States
Lexicon Investigational Site
Berlin, New Jersey, United States
Lexicon Investigational Site
Albuquerque, New Mexico, United States
Lexicon Investigational Site
Great Neck, New York, United States
Lexicon Investigational Site
Great Neck, New York, United States
Lexicon Investigational Site
New York, New York, United States
Lexicon Investigational Site
Boone, North Carolina, United States
Lexicon Investigational Site
Cary, North Carolina, United States
Lexicon Investigational Site
Chapel Hill, North Carolina, United States
Lexicon Investigational Site
Greensboro, North Carolina, United States
Lexicon Investigational Site
High Point, North Carolina, United States
Lexicon Investigational Site
Raleigh, North Carolina, United States
Lexicon Investigational Site
Winston-Salem, North Carolina, United States
Lexicon Investigational Site
Fargo, North Dakota, United States
Lexicon Investigational Site
Kettering, Ohio, United States
Lexicon Investigational Site
Lima, Ohio, United States
Lexicon Investigational Site
Mentor, Ohio, United States
Lexicon Investigational Site
Wadsworth, Ohio, United States
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Norman, Oklahoma, United States
Lexicon Investigational Site
Oklahoma City, Oklahoma, United States
Lexicon Investigational Site
Eugene, Oregon, United States
Lexicon Investigational Site
Mt. Pleasant, South Carolina, United States
Lexicon Investigational Site
Chattanooga, Tennessee, United States
Lexicon Investigational Site
Austin, Texas, United States
Lexicon Investigational Site
El Paso, Texas, United States
Lexicon Investigational Site
Lake Jackson, Texas, United States
Lexicon Investigational Site
Plano, Texas, United States
Lexicon Investigational Site
San Antonio, Texas, United States
Lexicon Investigational Site
Clinton, Utah, United States
Lexicon Investigational Site
Logan, Utah, United States
Lexicon Investigational Site
Ogden, Utah, United States
Lexicon Investigational Site
Sandy City, Utah, United States
Lexicon Investigational Site
West Jordan, Utah, United States
Lexicon Investigational Site
Lynchburg, Virginia, United States
Lexicon Investigational Site
Virginia Beach, Virginia, United States
Countries
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References
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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.
Other Identifiers
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LX1033.201
Identifier Type: OTHER
Identifier Source: secondary_id
LX1033.1-201-IBS
Identifier Type: -
Identifier Source: org_study_id
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