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The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Capsules for oral administration |
|
| ALKS 37 | Experimental | Capsules for oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 37 | Drug | Capsules for oral administration |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the weekly average of complete spontaneous bowel movements during treatment | Weeks 1 through 4 of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Leigh-Pemberton, M.D. | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational Site | Anaheim | California | 92804 | United States | ||
| Alkermes Investigational Site |
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| Drug |
Capsules for oral administration |
|
| Orange |
| California |
| 92868 |
| United States |
| Alkermes Investigational Site | Daytona Beach | Florida | 32117 | United States |
| Alkermes Investigational Site | Plantation | Florida | 33317 | United States |
| Alkermes Investigational Site | Marietta | Georgia | 30060 | United States |
| Alkermes Investigational Site | Indianapolis | Indiana | 46250 | United States |
| Alkermes Investigational Site | Las Vegas | Nevada | 89119 | United States |
| Alkermes Investigational Site | Willingboro | New Jersey | 08046 | United States |
| Alkermes Investigational Site | Raleigh | North Carolina | 27612 | United States |
| Alkermes Investigational Site | Philadelphia | Pennsylvania | 19139 | United States |
| Alkermes Investigational Site | Austin | Texas | 78756 | United States |
| Alkermes Investigational Site | Houston | Texas | 77098 | United States |
| Alkermes Investigational Site | Bellevue | Washington | 98007 | United States |