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The purpose of this study is to evaluate the safety, tolerability and efficacy of ALKS 37 when administered daily for 4 weeks to adults with Opioid-induced Constipation (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 |
|---|---|---|
| Dose response relationship among five doses of study drug (4 doses of ALKS 37 and placebo), defined as an increasing proportion of patients exhibiting overall response. | Overall response will be defined using an algorithm that takes into consideration number of complete spontaneous bowel movements, improvement from baseline, and durability of response. | 4 weeks |
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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 Study Site | Mesa | Arizona | 85206 | United States | ||
| Alkermes Study Site |
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| Drug |
Capsules for oral administration |
|
| Phoenix |
| Arizona |
| 85053 |
| United States |
| Alkermes Study Site | National City | California | 91950 | United States |
| Alkermes Study Site | Oceanside | California | 92056 | United States |
| Alkermes Study Site | Pasadena | California | 91105 | United States |
| Alkermes Study Site | Denver | Colorado | 80211 | United States |
| Alkermes Investigational Site | DeLand | Florida | 32724 | United States |
| Alkermes Study Site | Ormond Beach | Florida | 32174 | United States |
| Alkermes Study Site | St. Petersburg | Florida | 33709 | United States |
| Alkermes Study Site | Stockbridge | Georgia | 30281 | United States |
| Alkermes Study Site | Boise | Idaho | 83704 | United States |
| Alkermes Study Site | New Orleans | Louisiana | 70114 | United States |
| Alkermes Study Site | Kalamazoo | Michigan | 49009 | United States |
| Alkermes Study Site | Las Vegas | Nevada | 89144 | United States |
| Alkermes Study Site | Belvidere | New Jersey | 07823 | United States |
| Alkermes Study Site | Brooklyn | New York | 11218 | United States |
| Alkermes Study Site | Cincinnati | Ohio | 45224 | United States |
| Alkermes Study Site | Oklahoma City | Oklahoma | 73134 | United States |
| Alkermes Study Site | Medford | Oregon | 97504 | United States |
| Alkermes Study Site | San Antonio | Texas | 78228 | United States |
| ID | Term |
|---|---|
| D000079689 | Opioid-Induced Constipation |
| ID | Term |
|---|---|
| D003248 | Constipation |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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