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The purpose of this study is to assess the safety and tolerability of RDC-1036 (ALKS 37) in adults with opioid-induced constipation (OIC) following repeat dose administration
Approximately 60 subjects will be enrolled in 1 of 2 cohorts. Following a review of Cohort 1 safety and tolerability data, subjects will then be enrolled into Cohort 2, to explore additional doses. Dose escalation will occur in both cohorts. There will be 18 visits over a 6-week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RDC-1036 (ALKS 37) | Experimental | Capsules for oral administration |
|
| Placebo | Placebo Comparator | Capsules for oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RDC-1036 (ALKS 37) | Drug | Capsules for oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in frequency of spontaneous bowel movement (SBM) from pre-treatment period to treatment period | 4 Weeks | |
| Number of subjects reporting treatment-emergent adverse events (TEAEs) | A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period). | 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in rescue laxative use from pre-treatment to treatment period | 4 Weeks | |
| Study drug dose prior to first SBM after randomization | 4 weeks | |
| Scores to study-related questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard L. Silverman, MD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational Site | Sheffield | Alabama | 35660 | United States | ||
| Alkermes Investigational Site |
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| Placebo |
| Drug |
Capsules for oral administration |
|
| 6 weeks |
| Anaheim |
| California |
| 92801 |
| United States |
| Alkermes Investigational Site | Pasadena | California | 91105 | United States |
| Alkermes Investigational Site | Walnut Creek | California | 94598 | United States |
| Alkermes Investigational Site | DeLand | Florida | 32734 | United States |
| Alkermes Investigative Site | New Smyrna Beach | Florida | 32168 | United States |
| Alkermes Investigational Site | Boise | Idaho | 83704 | United States |
| Alkermes Investigational Site | New Orleans | Louisiana | 70114 | United States |
| Alkermes Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Alkermes Investigational Site | Dayton | Ohio | 45432 | United States |
| Alkermes Investigational Site | Salt Lake City | Utah | 84106 | 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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