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The purpose of this study is to evaluate the efficacy of DNK333 compared to placebo for relieving symptoms of IBS-D in female patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNK333 | Drug | DNK333 25mg b.i.d. given orally for 4 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfactory relief of IBS-related abdominal pain/discomfort | 4 weeks | |
| Satisfactory relief of overall IBS-D symptoms | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence and control of bowel urgency | 4 weeks | |
| Change in stool frequency | 4 weeks | |
| Severity of abdominal bloating |
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Inclusion criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals Corp. | NPC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Tucson | Arizona | 85712 | United States | ||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21507028 | Result | Zakko S, Barton G, Weber E, Dunger-Baldauf C, Ruhl A. Randomised clinical trial: the clinical effects of a novel neurokinin receptor antagonist, DNK333, in women with diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2011 Jun;33(12):1311-21. doi: 10.1111/j.1365-2036.2011.04656.x. Epub 2011 Apr 20. |
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| Drug |
Matching placebo |
|
| 4 weeks |
| Severity of abdominal pain/discomfort | 4 weeks |
| Safety | 4 weeks |
| North Little Rock |
| Arkansas |
| 72114 |
| United States |
| Investigative Site | Los Angeles | California | 90045-3119 | United States |
| Investigative Site | Orange | California | 92869 | United States |
| Investigative Site | Riverside | California | 92506 | United States |
| Investigative Site | Sacramento | California | 95825 | United States |
| Investigative Site | San Diego | California | 92108 | United States |
| Investigative Site | Colorado Springs | Colorado | 80904 | United States |
| Investigative Site | Bristol | Connecticut | 06010 | United States |
| Investigative Site | Hartford | Connecticut | 06010 | United States |
| Investigative Site | Boca Raton | Florida | 33486 | United States |
| Investigative Site | Gainesville | Florida | 32256 | United States |
| Investigative Site | Hollywood | Florida | 33021 | United States |
| Investigative Site | Jacksonville | Florida | 782091744 | United States |
| Investigative Site | Miami | Florida | 33173 | United States |
| Investigative Site | New Smyrna Beach | Florida | 32168-7327 | United States |
| Investigative Site | Tampa | Florida | 33607 | United States |
| Investigative Site | Arlington Heights | Illinois | 60005 | United States |
| Investigative Site | Rockford | Illinois | 61107 | United States |
| Investigative Site | Boston | Massachusetts | 02215 | United States |
| Investigative Site | Wellesley Hills | Massachusetts | 02481-2106 | United States |
| Investigative Site | Mexico | Missouri | 65265-3726 | United States |
| Investigative Site | Buffalo | New York | 14215 | United States |
| Investigative Site | Great Neck | New York | 11023-2432 | United States |
| Investigative Site | Elkin | North Carolina | 28621 | United States |
| Investigative Site | Cincinnati | Ohio | 45219 | United States |
| Investigative Site | Oklahoma City | Oklahoma | 73104 | United States |
| Investigative Site | Portland | Oregon | 97220 | United States |
| Investigative Site | Chattanooga | Tennessee | 37404 | United States |
| Investigative Site | Lake Jackson | Texas | 77566 | United States |
| Investigative Site | San Antonio | Texas | 78209-1744 | United States |
| Investigative Site | Salt Lake City | Utah | 84102 | United States |
| Investigative Site | Chesapeake | Virginia | 23320-1706 | United States |
| Investigative Site | Bellevue | Washington | 98004 | United States |
| Investigative Site | Everett | Washington | 98208 | United States |
| Investigative Site | Monroe | Washington | 98208 | United States |
| Investigative Site | Seattle | Washington | 98101 | United States |
| Investigative Site | Calgary | Alberta | T2N 4N1 | Canada |
| Investigative Site | St. John's | Newfoundland and Labrador | A1E 2E2 | Canada |
| Investigative Site | Hamilton | Ontario | L8N 3Z5 | Canada |
| Investigative Site | Montreal | Quebec | H2X 3J4 | Canada |
| Investigative Site | Québec | Quebec | G1S 4L8 | Canada |
| Investigative Site | Sherbrooke | Quebec | J1H 4J6 | Canada |
| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C448383 | DNK 333 |
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