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This will be a multi-center, randomized, double-blind, placebo-controlled study of YKP10811 capsules in patients with chronic idiopathic constipation. Following a 2-week baseline period, approximately 320 eligible patients with <3 complete spontaneous bowel movements (CSBM) and ≤ 5 SBMs per week will be randomly assigned equally to receive one of the following oral treatments; placebo or YKP10811 capsules once daily for 12 weeks followed by a 2 week follow-up period.
The objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Comparator | Placebo Comparator | Placebo Comparator |
|
| YKP10811 High Dose | Experimental | YKP10811 High Dose |
|
| YKP10811 Mid Dose | Experimental | YKP10811 Mid Dose |
|
| YKP10811 Low Dose | Experimental | YKP10811 Low Dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YKP10811 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with improved bowel movement frequency | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Stool frequency | 12 weeks | |
| Daily average ratings of stool consistency | 12 weeks | |
| Instances of rescue medicine usage |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alliance Clinical Research | Birmingham | Alabama | 35213 | United States | ||
| Clinical Research Advantage, Inc. / Warner Family Practice, PC |
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| Drug |
|
| 12 weeks |
| Onset time to CSBM | 12 weeks |
| Onset time to SBM | 12 weeks |
| Severity of straining | 12 weeks |
| Abdominal discomfort | 12 weeks |
| Abdominal pain | 12 weeks |
| Bloating | 12 weeks |
| Constipation severity | 12 weeks |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Connect Clinical Research Center | Chandler | Arizona | 85224 | United States |
| Clinical Research Advantage, Inc. / Central Phoenix Medical Clinic, LLC | Phoenix | Arizona | 85020 | United States |
| Arizona Research Center | Phoenix | Arizona | 85023 | United States |
| Applied Research Center Arkansas, Inc. | Little Rock | Arkansas | 72212 | United States |
| Digestive & Liver Disease Specialists, A Medical Group, Inc. | Anaheim | California | 92801 | United States |
| Precision Research Institute | Chula Vista | California | 91910 | United States |
| Triwest Research Associates, LLC | El Cajon | California | 92020 | United States |
| Diagnamics Inc. | Encinitas | California | 92024 | United States |
| Therapeutic Research Institute of Orange County | Laguna Hills | California | 92653 | United States |
| Clinical Trials Research | Lincoln | California | 95648 | United States |
| Alliance Clinical Research | Oceanside | California | 92056 | United States |
| Northern California Research | Sacramento | California | 95821 | United States |
| Clinical Research Advantage, Inc. / Colorado Springs Health Partners, SW | Colorado Springs | Colorado | 80906 | United States |
| Meridien Research | Bradenton | Florida | 34208 | United States |
| Palm Springs Research Institute | Hialeah | Florida | 33012 | United States |
| The Clinical Research Institute | Miami | Florida | 33125 | United States |
| Prestige Clinical Research Center Inc. | Miami | Florida | 33133 | United States |
| Physicians Regional Medical Group | Naples | Florida | 34119 | United States |
| Advanced Gastroenterology Associates, LLC | Palm Harbor | Florida | 34684 | United States |
| Clinical Research Trials of Florida, Inc. | Tampa | Florida | 33607 | United States |
| River Birch Research Alliance, LLC | Blue Ridge | Georgia | 30513 | United States |
| Gastroenterology Associates of Central Georgia, LLC | Macon | Georgia | 31201 | United States |
| Gastrointestinal Specialists of Georgia | Marietta | Georgia | 30060 | United States |
| North Georgia Clinical Research | Woodstock | Georgia | 30189 | United States |
| May Medical Center | Chicago | Illinois | 60624 | United States |
| Pharmakon Inc. | Evergreen Park | Illinois | 60805 | United States |
| Clinical Research Advantage, Inc. | Evansville | Indiana | 47714 | United States |
| KAMP Medical Research, Inc. | Natchitoches | Louisiana | 71457 | United States |
| Clinical Associates Ambulatory Surgical Center | Towson | Maryland | 21286 | United States |
| The Research Institute | Springfield | Massachusetts | 01105 | United States |
| Coastal Research Associates, Inc. | Weymouth | Massachusetts | 02190 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | United States |
| Clinical Research Advantage, Inc. | Henderson | Nevada | 89052 | United States |
| AB Clinical Trials | Las Vegas | Nevada | 89119 | United States |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89130 | United States |
| Las Vegas | Nevada | 89144 | United States |
| AGA Clinical Research Associates, LLC | Egg Harbor | New Jersey | 08234 | United States |
| HBSA, A Supporting Organization of Pacific Institute for Research and Evaluation | Albuquerque | New Mexico | 87102 | United States |
| NY Scientific | Brooklyn | New York | 11235 | United States |
| Medex Healthcare Research, Inc. | New York | New York | 10016 | United States |
| PMG Research of Charlotte | Charlotte | North Carolina | 28209 | United States |
| PMG Research of Charlotte | Concord | North Carolina | 28025 | United States |
| PMG Research of Hickory, LLC | Hickory | North Carolina | 28605 | United States |
| PMG Research of Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| Dayton Gastroenterology, Inc. | Beavercreek | Ohio | 45440 | United States |
| Consultants for Clinical Research | Cincinnati | Ohio | 45219 | United States |
| Hilltop Physicians IN / Hightop Medical Research Center | Cincinnati | Ohio | 45224 | United States |
| New Horizons Clinical Research | Cincinnati | Ohio | 45242 | United States |
| Columbus Clinical Research Inc. | Columbus | Ohio | 43213 | United States |
| COR Clinical Research, LLC | Oklahoma City | Oklahoma | 73103 | United States |
| Options Health Research, LLC | Tulsa | Oklahoma | 74104 | United States |
| Sunstone Medical Research, LLC | Medford | Oregon | 97504 | United States |
| The Oregon Clinic, PC - Gastroenterology West | Portland | Oregon | 97225 | United States |
| Clinical Trials Research Services, LLC | Pittsburgh | Pennsylvania | 15206 | United States |
| Partners in Clinical Research, LLC | Cumberland | Rhode Island | 02864 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| Alpha Clinical Research, LLC | Clarksville | Tennessee | 37043 | United States |
| Austin Center for Clinical Research | Austin | Texas | 78756 | United States |
| MW Clinical Research Center | Beaumont | Texas | 77702 | United States |
| Houston Endoscopy & Research Center | Houston | Texas | 77079 | United States |
| Sun Research Institute | San Antonio | Texas | 78215 | United States |
| Radiant Research Inc. | San Antonio | Texas | 78229 | United States |
| Digestive Health Specialists of Tyler, LLP | Tyler | Texas | 75701 | United States |
| Advanced Research Institute | Ogden | Utah | 84405 | United States |
| Health Research of Hampton Roads, Inc. | Newport News | Virginia | 23606 | United States |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | United States |
| ID | Term |
|---|---|
| C000600155 | carbamic acid 3-(4-((4-amino-5-chloro-2-methoxybenzoylamino)methyl)piperidin-1-yl)-1-(4-fluorophenyl)propyl ester |
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