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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01258569 | Entereg Laparoscopic Colon Resection Study | PHASE2 | COMPLETED | 135 | — | — | Nov 1, 2010 | Jul 1, 2015 | Aug 26, 2015 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Entereg | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Entereg | DRUG | Alvimopan (Entereg), an oral peripherally- acting mu-opioid receptor antagonist, is the first and only drug approved by the FDA to accelerate the time to upper and lower GI recovery in after partial large or small bowel resection surgery with primary anastomosis. |
| placebo | DRUG | 12 mg oral 30-300 min pre-op then BID up to 7 days (or 15 doses) |
Inclusion Criteria: Subject is scheduled to undergo laparoscopic (straight or hand assisted) elective colon resection with primary anastamosis Subject is \>18 years of age Subjects can be either male or female Negative pregnancy test (if patient is a premenopausal female) Medically stable as determ...