A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open-label arm for midazolam, in patients undergoing a colonoscopy for diagnostic or therapeutic reasons.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
461
For induction and maintenance of sedation
For induction of maintenance and sedation
Inactive control arm
University of South Alabama
Mobile, Alabama, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Precision Research Institute
Chula Vista, California, United States
Success Rates of the Procedure
Success of the Procedure is measured by completion of colonoscopy, no requirement for an alternative sedative and no requirement for more than 5 top-ups of study medication within any 15 minute period in the blinded arms (remimazolam/placebo) or no requirement for more than 3 doses within any 12 minute window in the midazolam arm.
Time frame: From administration of the first dose of the study drug to the end of colonoscopy
Time to Start of Procedure
The time to the start of the procedure after administration of the first dose of randomized study drug
Time frame: From first dose of study drug until insertion of the colonoscope
Time to Fully Alert
The time to fully alert (time to first of three consecutive Modified Observer's Assessment of Alertness/Sedation \[MOAA/S\] scores of 5) after the end of colonoscopy procedure \[colonoscope out\], and after the last dose of study drug or rescue sedative medication
Time frame: From the end of colonoscopy (colonoscope out) until the patient has recovered to fully alert and from the last injection of the study drug or rescue sedative medication until the patient has recovered to fully alert
Time to Ready for Discharge
The time after the end of colonoscopy procedure (colonoscope out) and after the last injection of study drug or rescue sedative medication, until discharge (defined as ability to walk unassisted).
Time frame: From the end of the colonoscopy until discharge (expected to be the same day). After the last dose of study drug or rescue sedative, until discharge (expected to be the same day).
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Precision Research Institute
San Diego, California, United States
Borland-Grover Clinic, P.A
Jacksonville, Florida, United States
Indiana University Health
Indianapolis, Indiana, United States
Delta Research Partners Inc
Monroe, Louisiana, United States
Washington University School of Medicine
St Louis, Missouri, United States
Wake Research Associates
Raleigh, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
...and 3 more locations