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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01382797 | ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC) | PHASE2 | COMPLETED | 157 | — | — | Aug 1, 2011 | Apr 1, 2012 | Jun 13, 2012 | 20 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Capsules for oral administration |
| ALKS 37 | EXPERIMENTAL | Capsules for oral administration |
| Name | Type | Description |
|---|---|---|
| ALKS 37 | DRUG | Capsules for oral administration |
| Placebo | DRUG | Capsules for oral administration |
Inclusion Criteria: * Are at least 18 years of age at time of consent * Have a body mass index (BMI)of 19 to 35 kg/m2 at screening * Are receiving prescribed opioid medication for the management of chronic, non-cancer pain * Meet the criteria of OIC * Agree to use an acceptable method of contracept...