A Phase 2 interventional study of ABP-700 in Colonoscopy, sponsored by The Medicines Company. Completed at 3 sites in Netherlands. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-02-20.
Sponsored by The Medicines Company (part of Novartis) · Phase 2, Interventional, and Treatment
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.
The Medicines Company is the lead sponsor of 50 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
First submitted before The Medicines Company became part of Novartis.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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.
Drug: ABP-700
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.
Drug: ABP-700
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.
Drug: ABP-700
Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose
Time frame: Treatment period (Day 1)
Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose with and without Supplemental Bolus ABP-700
Time frame: 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
Time frame: Treatment period (Day 1)
Time to Procedure Start
Time frame: Treatment period (Day 1)
Depth and Duration of Sedation
Time frame: Treatment period (Day 1)
Number of Supplemental ABP-700 Bolus Doses Required
Time frame: Treatment period (Day 1)
Recovery from Sedation and Discharge Conditions as Assessed by the Modified Aldrete Score (APRS)
Time frame: Treatment period (Day 1)
Plan to share: No
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Ran from May 2016 to primary completion in Jun 2017, 13 months.
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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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