Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01100151 | ALK37-003: A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation (OIC) | PHASE2 | COMPLETED | 60 | — | — | Apr 1, 2010 | Dec 1, 2010 | Aug 23, 2011 | 11 | United States |
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).
| Arm | Type | Description |
|---|---|---|
| RDC-1036 (ALKS 37) | EXPERIMENTAL | Capsules for oral administration |
| Placebo | PLACEBO_COMPARATOR | Capsules for oral administration |
| Name | Type | Description |
|---|---|---|
| RDC-1036 (ALKS 37) | DRUG | Capsules for oral administration |
| Placebo | DRUG | Capsules for oral administration |
Inclusion Criteria: * 18 to 70 years of age * Body mass index (BMI) of 19 to 35 kg/m2 at screening * Receiving prescribed opioid medication for the management of chronic, non-cancer, pain * Diagnosis of opioid-induced constipation (OIC) * Willingness to stop all laxatives and other bowel regimens f...