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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00751478 | Study to Determine the Bioavailability, Pharmacodynamic Effects, and Safety of Whole and Crushed ALO-01 Compared to Morphine Sulfate Immediate Release (MSIR) | PHASE1 | COMPLETED | 32 | — | — | Mar 1, 2007 | May 1, 2007 | Sep 16, 2013 | 1 | Canada |
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | 2 Placebo capsules (whole) + ALO-01 2 x 60 mg capsules (crushed) in apple juice + apple juice (MSIR placebo) |
| B | EXPERIMENTAL | 2 x 60 mg ALO-01 (whole) + 2 x placebo capsules (crushed) in apple juice + apple juice (MSIR placebo) |
| C | ACTIVE_COMPARATOR | 2 x placebo capsules (whole) + 2 X placebo capsules (crushed) in apple juice + 120 mg MSIR in apple juice |
| D | PLACEBO_COMPARATOR | 2 x placebo capsules (whole) + 2 X placebo capsules (crushed) in apple juice + apple juice (MSIR placebo) |
| Name | Type | Description |
|---|---|---|
| ALO-01 | DRUG | ALO-01 capsules |
| MSIR | DRUG | immediate release morphine sulfate |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Male or female subjects 18 to 55 years of age, inclusive. * Subjects had to be opioid users who were not currently physically dependent on opioids (based on DSM-IV criteria) but had experience in the use of opioids for non-therapeutic purposes (i.e. for psychoactive effects) o...