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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01084161 | Study to Evaluate the Efficacy, Safety and Tolerability of N1539 | PHASE2 | COMPLETED | 486 | — | — | Mar 1, 2010 | Jan 1, 2011 | Dec 2, 2011 | 12 | Georgia, Poland +1 |
Additionally, to determine the efficacy seen within the first hour after study drug administration, as measured by the SPID 0-60 minutes post-dose.
| Arm | Type | Description |
|---|---|---|
| N1539 5 mg | EXPERIMENTAL | - |
| N1539 7.5 mg | EXPERIMENTAL | - |
| N1539 15 mg | EXPERIMENTAL | - |
| N1539 30 mg | EXPERIMENTAL | - |
| N1539 60 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| morphine | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| N1539 | DRUG | 5 mg IV once per day |
| placebo | DRUG | IV placebo once per day |
| Morphine | DRUG | morphine 10-15 mg IV once per day |
Inclusion Criteria: * moderate to severe pain with VAS of \>/= 45 mm * undergo open abdominal hysterectomy * ASA I or II * signed ICF * BMI \>18.5 and \< 31.5 kg/m\^2 Exclusion Criteria: * suspected metastatic cervical or endometrial cancer * prior abdominal surgery with postoperative complicatio...