Study of LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome
NCT ID: NCT00813098
Last Updated: 2010-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
155 participants
INTERVENTIONAL
2008-12-31
2010-08-31
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
TRIPLE
Study Groups
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High dose
A high dose of LX1031; daily oral intake for 28 days
LX1031 High Dose
A high dose of LX1031; daily oral intake for 28 days
Low Dose
A low dose of LX1031; daily oral intake for 28 days
LX1031 Low Dose
A low dose of LX1031; daily oral intake for 28 days.
Placebo
Matching placebo dosing with daily oral intake
Placebo
Matching placebo dosing with daily oral intake
Interventions
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LX1031 High Dose
A high dose of LX1031; daily oral intake for 28 days
LX1031 Low Dose
A low dose of LX1031; daily oral intake for 28 days.
Placebo
Matching placebo dosing with daily oral intake
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
70 Years
ALL
No
Sponsors
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Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
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Lexicon Pharmaceuticals, Inc.
Principal Investigators
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Joel P. Freiman, MD
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals, Inc.
Locations
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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
Consultants for Clinical Research of S. Florida
Boynton Beach, Florida, United States
Research Consultants Group
Hialeah, Florida, United States
Accord Clinical Research, LLC
Port Orange, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Northwest Clinical Trials
Boise, Idaho, United States
ActivMed Practice and Research
Haverhill, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Affiliated Clinical Research
Las Vegas, Nevada, United States
Long Island Clinical Research
Great Neck, New York, United States
Cary Medical Research
Cary, North Carolina, United States
The UNC Center for Functional GI & Motility Disorders
Chapel Hill, North Carolina, United States
Medoff Medical/Vital re:Search
Greensboro, North Carolina, United States
Unifour Medical Research
Hickory, North Carolina, United States
Piedmont Medical Associates
Winston-Salem, North Carolina, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
Gastroenterology Research Consultant of Greater Cincinnati
Cincinnati, Ohio, United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Coastal Carolina Research Center in Goose Creek
Goose Creek, South Carolina, United States
ClinSearch
Chattanooga, Tennessee, United States
Pioneer Research Solutions
Houston, Texas, United States
Houston Medical Research Associates
Houston, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
Utah Clinical Trials, LLC
Salt Lake City, Utah, United States
National Clinical Research Norfolk Inc.
Norfolk, Virginia, United States
Aurora Health Center - Waukesha
Waukesha, Wisconsin, United States
Countries
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Other Identifiers
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LX1031.201
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol LX1031.1-201-IBS
Identifier Type: -
Identifier Source: org_study_id