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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00728832 | A Pharmacokinetic (PK) Study of Extended-Release Epidural Morphine in Upper Abdominal Surgery | PHASE1 | COMPLETED | 39 | — | — | May 1, 2002 | - | Aug 14, 2008 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | No test dose + DepoDur + flush with 1 mL normal saline |
| 2 | EXPERIMENTAL | Test dose + flush with 1 mL normal saline + 3-minute wait + DepoDur + flush with 1 mL normal saline |
| 3 | EXPERIMENTAL | Test dose + flush with 1 mL normal saline + 10-minute wait + DepoDur + flush with 1 mL normal saline |
| 4 | EXPERIMENTAL | Test dose + flush with 1 mL normal saline + 15-minute wait + DepoDur + flush with 1 mL normal saline |
| 5 | EXPERIMENTAL | Test dose + No flush + 3-minute wait + DepoDur + flush with 1 mL normal saline |
| Name | Type | Description |
|---|---|---|
| DepoDur (extended-release epidural morphine) | DRUG | DepoDur with on demand boluses of IV fentanyl PCA |
Inclusion Criteria: * Males and females ≥ 18 years of age at Screening * Negative pregnancy test in females of childbearing potential * Scheduled for major upper abdominal surgery via an upper midline incision under general anesthesia * American Society of Anesthesiology (ASA) Physical Class 1, 2, ...