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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02800590 | Study to Investigate the Safety and Efficacy of 3 Dosing Regimens of ABP-700 for Procedural Sedation in Adult Participants Undergoing Colonoscopy | PHASE2 | COMPLETED | 150 | — | — | May 1, 2016 | Jun 1, 2017 | Feb 20, 2018 | 3 | Netherlands |
| Arm | Type | Description |
|---|---|---|
| ABP-700 30 μg/kg/min | EXPERIMENTAL | Starting intravenous (IV) infusion rate of 50 micrograms per kilogram per minute (μg/kg/min) for 5 minutes, followed by 30 μg/kg/min until the procedure is complete. Up to 2 supplemental bolus injections of 50 μg/kg ABP-700 separated by a minimum of 5 minutes may be administered in order to achieve and/or maintain adequate procedure conditions. |
| ABP-700 40 μg/kg/min | EXPERIMENTAL | Starting IV infusion rate of 70 μg/kg/min for 3 minutes, followed by 40 μg/kg/min until the procedure is complete. Up to 2 supplemental bolus injections of 50 μg/kg ABP-700 separated by a minimum of 5 minutes may be administered in order to achieve and/or maintain adequate procedure conditions. |
| ABP-700 45 μg/kg/min | EXPERIMENTAL | Starting IV infusion rate of 80 μg/kg/min for 3 minutes, followed by 45 μg/kg/min until the procedure is complete. Up to 2 supplemental bolus injections of 50 μg/kg ABP-700 separated by a minimum of 5 minutes may be administered in order to achieve and/or maintain adequate procedure conditions. |
| Name | Type | Description |
|---|---|---|
| ABP-700 | DRUG | - |
Inclusion Criteria: * Participant must be male or female 18 to 75 years of age, inclusive * Participant must give written informed consent before initiation of any study-related procedures * Participant is scheduled to undergo elective colonoscopy * Body Mass Index (BMI) 18.0 to 29.0 kilogram per m...