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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01961349 | Phase III Study of ICI35,868 (Diprivan) With and Without EES0000645/A (SDS) on Gastrointestinal Endoscopy | PHASE3 | COMPLETED | 279 | — | — | Oct 1, 2013 | Mar 1, 2014 | Nov 27, 2015 | 3 | Japan |
The target sedation is defined as MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scores 2 to 4 for ≥50% of all MOAA/S measurements from scope-in to scope-out.
| Arm | Type | Description |
|---|---|---|
| Group 1 | PLACEBO_COMPARATOR | Group 1 (placebo group) is treated by Anaesthesiologist |
| Group 2 | ACTIVE_COMPARATOR | Group 2 (ICI35,868 without EES0000645/A) is treated by Anaesthesiologist |
| Group 3 | ACTIVE_COMPARATOR | Group 3 (ICI35,868 with EES0000645/A) is treated by Endoscopist |
| Name | Type | Description |
|---|---|---|
| Intralipid | DRUG | Treated by Anaesthesiologist. (Intralipid is being used as a placebo for Diprivan.) |
| ICI35,868 (Diprivan) | DRUG | Treated by Anaesthesiologist |
| ICI35,868 (Diprivan) + EES0000645/A (SDS) | DRUG | Treated by Endoscopist with EES0000645/A(SDS) |
Inclusion Criteria: 1.Provision of written informed consent prior to any study-related procedures/examinations 2.Aged 20 years and older 3.Subjects who are planned to undergo a non-emergent EGD or colonoscopy, including gastrointestinal endoscopic polypectomy that shall be completed within 1 hour (...