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This study will evaluate the safety and effectiveness of the investigational drug DDP733 in treating female patients with IBS-c. A placebo control will be utilized.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DDP733 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Subject Global Assessment (SGA) of relief of IBS symptoms, collected weekly |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly assessments of abdominal discomfort/pain, bowel habit, and satisfaction with bowel habit. | ||
| Other secondary efficacy variables reflecting IBS symptoms include daily assessments of abdominal discomfort/pain; abdominal bloating, the number and consistency of stools, straining at defecation, and feeling of incomplete evacuation. |
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Inclusion Criteria:
Female from 18 to 65 years of age, inclusive
Patient experiences recurrent abdominal pain or discomfort at least 3 days per month for the last 3 months with symptom onset at least 6 months prior to diagnosis. The patient's symptoms must be associated with 1 or more of the following:
Negative serum and urine pregnancy tests
Completion of at least six days of daily diary assessments using a phone-in information system prior to randomization
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dynogen Study Director, MD | Dynogen Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alliance Clinical Trials | Recruiting | Birmingham | Alabama | 35215 | United States |
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| Clinical Research Associates | Recruiting | Huntsville | Alabama | 35801 | United States |
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| Medical Affiliated Research Center, Inc. | Recruiting | Huntsville | Alabama | 35801 | United States |
|
| Mobile Medical Diagnostic | Recruiting | Mobile | Alabama | 36617 | United States |
|
| Pivotal Research Centers | Recruiting | Peoria | Arizona | 85381 | United States |
|
| Genova Clinical Research | Recruiting | Tucson | Arizona | 85741 | United States |
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| Arkansas Gastroenterology | Recruiting | Sherwood | Arkansas | 72120 | United States |
|
| Impact Clinical Trials | Recruiting | Beverly Hills | California | 90211 | United States |
|
| Discovery Clinical Research | Recruiting | Encinitas | California | 92024 | United States |
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| Family Medical Center | Recruiting | Foothill Ranch | California | 92610 | United States |
|
| Digestive and Liver Disease Specialist, A Medical Group, Inc. | Recruiting | Garden Grove | California | 92840 | United States |
|
| Prime Care Clinical Research, Inc. | Recruiting | Mission Vejo | California | 92691 | United States |
|
| California Research Foundation | Recruiting | San Diego | California | 92103 | United States |
|
| Medical Center for clinical research | Recruiting | San Diego | California | 92108 | United States |
|
| Westlake Medical Research | Recruiting | Westlake Village | California | 91361 | United States |
|
| Clinical Trial Center of Colorado, LLC | Recruiting | Castle Rock | Colorado | 80108 | United States |
|
| Clinical Trials Management of Boca Raton, Inc. | Recruiting | Boca Raton | Florida | 33486 | United States |
|
| Jupiter Research | Recruiting | Jupiter | Florida | 33458 | United States |
|
| AppleMed Research Inc. | Recruiting | Miami | Florida | 33155 | United States |
|
| Accord Clinical Research, LLC | Recruiting | Port Orange | Florida | 32129 | United States |
|
| Stedman Clinical Trials | Recruiting | Tampa | Florida | 33613 | United States |
|
| Mount Vernon Clinical Research | Recruiting | Atlanta | Georgia | 30328 | United States |
|
| Atlanta Gastroenterology Associates, LLC | Recruiting | Marietta | Georgia | 30067 | United States |
|
| North Georgia Clinical Research | Recruiting | Woodstock | Georgia | 30189 | United States |
|
| Rosemark WomenCare Specialists | Recruiting | Idaho Falls | Idaho | 83404 | United States |
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| Accelovance | Recruiting | Peoria | Illinois | 61602 | United States |
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| Rockford Gastroenterology Associates, Ltd. | Recruiting | Rockford | Illinois | 61107 | United States |
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| Indiana Medical Research, LLC | Recruiting | Elkhart | Indiana | 46514 | United States |
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| MediSphere Medical Research Center, LLC | Recruiting | Evansville | Indiana | 47714 | United States |
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| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
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| Heartland Research Associates, LLC | Recruiting | Wichita | Kansas | 67203 | United States |
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| Louisiana Research Center, LLC | Recruiting | Shreveport | Louisiana | 71103 | United States |
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| Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research | Recruiting | Chevy Chase | Maryland | 20815 | United States |
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| Maryland Digestive Disease Research, LLC | Recruiting | Laurel | Maryland | 20707 | United States |
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| Boston Clinical Trials, INC. | Recruiting | Boston | Massachusetts | 02135 | United States |
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| Women's Health Care Specialists, PC | Recruiting | Paw Paw | Michigan | 49079 | United States |
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| CRC of Jackson, LLC at Jackson Medical Clinic | Recruiting | Jackson | Mississippi | 39202 | United States |
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| Gastrointestinal Associates, P.A. | Recruiting | Jackson | Mississippi | 39202 | United States |
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| Center for Digestive and Liver Diseases, Inc. | Recruiting | Mexico | Missouri | 65265 | United States |
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| Lovelace Scientific Resources | Recruiting | Henderson | Nevada | 89014 | United States |
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| LifeLine Research, Inc. | Recruiting | Brooklyn | New York | 11214 | United States |
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| UNC Center for Functional GI and Motility Disorders | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
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| Peters Medical Research dba Bethany Medical Center | Recruiting | High Point | North Carolina | 27262 | United States |
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| Wake Research Associates, LLC | Recruiting | Raleigh | North Carolina | 27612 | United States |
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| Piedmont Medical Research Associates | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
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| Hightop Medical Research Center | Recruiting | Cincinnati | Ohio | 45224 | United States |
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| Gastroenterology Research Consultants of Greater Cincinnati | Recruiting | Cincinnati | Ohio | 45242 | United States |
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| Rapid Medical Research, Inc. | Recruiting | Cleveland | Ohio | 44122 | United States |
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| Gastrointestinal and Liver Diseases Consultants | Recruiting | Dayton | Ohio | 45440 | United States |
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| Clinical Trials Research Services, LLC | Recruiting | Pittsburgh | Pennsylvania | 15206 | United States |
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| Southeastern Clinical Research | Recruiting | Chattanooga | Tennessee | 37403 | United States |
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| Jackson Clinic, PA | Recruiting | Jackson | Tennessee | 38301 | United States |
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| Regional Research Institute | Recruiting | Jackson | Tennessee | 38305 | United States |
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| Gastroenterology Associates Clinical Research | Recruiting | Kingsport | Tennessee | 37660 | United States |
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| Baylor College of Medicine, Baylor Clinic | Recruiting | Houston | Texas | 77030 | United States |
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| DCOL Center for Research | Recruiting | Longview | Texas | 75605 | United States |
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| Advanced Research Institute | Recruiting | Ogden | Utah | 84405 | United States |
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| Virginia Mason Meidical Center | Recruiting | Seattle | Washington | 98101 | United States |
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| Rowan Research | Recruiting | Spokane | Washington | 99207 | United States |
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| Spokane Internal Medicine | Recruiting | Spokane | Washington | 99216 | United States |
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| Wisconsin Center for Advanced Research Division of GI Associates, LLC | Recruiting | Milwaukee | Wisconsin | 53215 | United States |
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| Aurora Health Center | Recruiting | Waukesha | Wisconsin | 53186 | United States |
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| McMaster University Dept of Gastrointerology St. Joseph's Healthcare | Recruiting | Hamilton | Ontario | L8N4A6 | Canada |
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| St. Joseph's Hospital | Recruiting | London | Ontario | N6A 4V2 | Canada |
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| Meadowlands Family Health Center | Recruiting | Ottawa | Ontario | K2C 3R2 | Canada |
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| London Road Diagnostic Clinic | Recruiting | Sarnia | Ontario | N7T4X3 | Canada |
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| Sarnia Institute of Clinical Research | Recruiting | Sarnia | Ontario | N7T4X3 | Canada |
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| Canadian Phase Onward Inc. | Recruiting | Toronto | Ontario | M3H 5S4 | Canada |
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| Toronto Digestive Disease Associates, Inc. | Recruiting | Toronto | Ontario | M3N2V7 | Canada |
|
| 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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| ID | Term |
|---|---|
| C527576 | DDP733 |
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