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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01189604 | Dose Rate Range Finding Study of Propofol for minimal-to Moderate Sedation on Upper & Lower Endoscopic Tests | PHASE2 | COMPLETED | 123 | — | — | Aug 1, 2010 | Nov 1, 2010 | Dec 19, 2011 | 2 | Japan |
The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \[trapezius squeeze\]) to 5 (Responds readily to name spoken in normal tone \[awake\]). MOAA/S scores were classified as 0-1, 2-4 and 5.
The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \[trapezius squeeze\]) to 5 (Responds readily to name spoken in normal tone \[awake\]). MOAA/S scores were classified as 0-1, 2-4 and 5.
| Arm | Type | Description |
|---|---|---|
| Arm1 - Placebo | PLACEBO_COMPARATOR | - |
| Arm 2 - ICI35,868 (propofol) | ACTIVE_COMPARATOR | - |
| Arm 3 - ICI35,868 (propofol) | ACTIVE_COMPARATOR | - |
| Arm 4 - ICI35,868 (propofol) | ACTIVE_COMPARATOR | - |
| Arm 5 - ICI35,868 (propofol) | ACTIVE_COMPARATOR | - |
| Arm 6 - ICI35,868 (propofol) | ACTIVE_COMPARATOR | - |
| Arm 7 - ICI35,868 (propofol) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Infusion of placebo, same infusion rates as for arm 2 |
| ICI35,868 (propofol) | DRUG | Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute |
Inclusion Criteria: * Male or female (females of child bearing potential to confirm not pregnant via test or contraception) * Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy, including polypectomy that shall be completed within 1 hour Exclusion Criteria: * American So...