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| ID | Type | Description | Link |
|---|---|---|---|
| LX1033.201 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose | Experimental | 500 mg LX1033 two times daily |
|
| Mid dose | Experimental | 500 mg LX1033 three times daily |
|
| High dose | Experimental | 1000 mg LX1033 two times daily |
|
| Placebo | Placebo Comparator | Matching placebo dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 250 mg LX1033 tablets | Drug | 250 mg LX1033 tablets administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in stool consistency | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in plasma 5-HIAA levels | 4 weeks | |
| Change from baseline in worst abdominal pain in past 24 hours | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sumen Wason, MD | Lexicon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexicon Investigational Site | Huntsville | Alabama | 35801 | United States | ||
| Lexicon Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28932269 | Derived | 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. Ther Adv Gastroenterol. 2017 Sep;10(9):673-687. doi: 10.1177/1756283X17726018. Epub 2017 Aug 24. |
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| Placebo tablet | Drug | Matching placebo tablet administered orally |
|
| 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 |
| Lexicon Investigational Site | Brooksville | Florida | 34601 | United States |
| Lexicon Investigational Site | DeLand | Florida | 32720 | United States |
| Lexicon Investigational Site | Jacksonville | Florida | 32256 | United States |
| Lexicon Investigational Site | 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 |
| Lexicon Investigational Site | Chicago | Illinois | 60622 | United States |
| Lexicon Investigational Site | Rockford | Illinois | 61107 | United States |
| Lexicon Investigational Site | 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 |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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