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The purpose of this study is to determine whether ATI-7505 is effective in the treatment of chronic idiopathic constipation.
This study is designed to evaluate the safety and efficacy of ATI 7505 in generally healthy, adult patients who have had symptoms of chronic idiopathic constipation for at least 6 months as defined in the ROME III criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | placebo twice daily |
|
| 2 | Experimental | 20 mg ATI-7505, BID for 4 weeks |
|
| 3 | Experimental | 40 mg ATI, BID, 4 weeks |
|
| 4 | Experimental | 80 mg ATI-4505, BID for 4 weeks |
|
| 5 | Experimental | 120 mg ATI-7505, BID for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATI-7505 | Drug | Tablet,placebo, BID |
| |
| ATI-7505 |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of spontaneous bowel movements during the first 7 days after randomization | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Daily and/or weekly assessments of the consistency, severity, frequency, symptoms of constipation during the treatment period | daily and or weekly |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tom G Todaro, MD | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Facility | Anaheim | California | United States | |||
| Research facility |
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| Drug |
ATI-7505 20 mg BID for 4 weeks |
|
| ATI-7505 | Drug | tablet, 40 mg, BID, $ weeks |
|
| ATI-7505 | Drug | 80 mg ATI-7505, BID for 4 weeks |
|
| ATI-7505 | Drug | 120 mg ATI-7505, BID, for 4 weeks |
|
| San Carlos |
| California |
| United States |
| Research Facility | San Diego | California | United States |
| Research Facility | Littleton | Colorado | United States |
| Research Facility | Aventura | Florida | United States |
| Research Facility | Hollywood | Florida | United States |
| Research Facility | South Miami | Florida | United States |
| Researrch Facility | Newnan | Georgia | United States |
| Research Facility | Rockford | Illinois | United States |
| Research Facility | Evansville | Indiana | United States |
| Research Facility | Boston | Massachusetts | United States |
| Research Facility | Great Neck | New York | United States |
| Research Facility | Lake Success | New York | United States |
| Research Facility | Cincinnati | Ohio | United States |
| Research Facility | Oklahoma City | Oklahoma | United States |
| Research Facility | Chattanooga | Tennessee | United States |
| Research Facility | Nashville | Tennessee | United States |
| Research Facility | Salt Lake City | Utah | United States |
| Research Facility | Charlottesville | Virginia | United States |
| Research Facility | Christiansburg | Virginia | United States |
| Research Facility | Montreal | Quebec | Canada |
| Reserach Facility | Québec | Quebec | Canada |
| Research Facility | Saint Charles Borremee | Quebec | Canada |
| ID | Term |
|---|---|
| C517618 | ATI 7505 |
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