Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004019-19 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase II, two-part, multiple-dose, dose-finding, single-blind study in adult participants undergoing elective colonoscopy for screening or diagnostic purposes. This study is designed to test various ABP-700 infusion regimens for rational selection of one or more dosage regimen(s) to be used for future clinical development of ABP-700 in procedural sedation.
In Part 1, three ABP-700 two-stage infusion regimens will be evaluated. A sample size of 75 evaluable participants will be randomly assigned to dose regimens in a 1:1:1 ratio. Following the completion of Part 1, a Data Review Committee (DRC) will review the dose-response, efficacy, and safety data and provide recommendations on whether to continue the study to Part 2 and the number of ABP-700 infusion regimens to be included in Part 2. The Sponsor (MDCO) will make the final decision to proceed with Part 2 (whether to conduct Part 2 and number of dose regimens if the study continues to Part 2) based on the recommendation from the DRC.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABP-700 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose | Treatment period (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose with and without Supplemental Bolus ABP-700 | Treatment period (Day 1) | |
| Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose with and without Supplemental Bolus ABP-700 that Require or Do Not Require Rescue Sedative Medication |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| A.R. Absalom, MD | University Medical Center Groningen (UMCG) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Martini Hospital | Groningen | Netherlands | ||||
| University Medical Center Groningen (UMCG) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Treatment period (Day 1) |
| Time to Procedure Start | Treatment period (Day 1) |
| Depth and Duration of Sedation | Treatment period (Day 1) |
| Number of Supplemental ABP-700 Bolus Doses Required | Treatment period (Day 1) |
| Recovery from Sedation and Discharge Conditions as Assessed by the Modified Aldrete Score (APRS) | Treatment period (Day 1) |
| Groningen |
| Netherlands |
| Radboud University Nijmegen Medical Centre | Nijmegen | Netherlands |
| ID | Term |
|---|---|
| C000712787 | abp-700 |
Not provided
Not provided
Not provided