The purpose of this dose-response study is to assess the safety and efficacy of CNS 7056 compared with midazolam to maintain suitable sedation levels in patients undergoing colonoscopy.
This is a double-blind, randomized, parallel group, dose-response study to assess the safety and efficacy of three dose levels of CNS 7056 compared with midazolam to maintain suitable sedation levels in patients undergoing colonoscopy. Safety assessment will include physical examinations, vital signs, ECGs, pulse oximetry measurements, capnography, clinical chemistry and hematology laboratory tests, routine drug and ethanol screening, urinalysis, pregnancy test, pain on injection using a verbal scale, and monitoring of adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
162
Initial low dose plus supplemental doses as necessary.
Initial intermediate dose plus supplemental doses as necessary.
Initial high dose plus supplemental doses as necessary.
Helen Keller Hospital
Sheffield, Alabama, United States
HOPE Research Institute
Phoenix, Arizona, United States
ACRI Phase I LLC
Anaheim, California, United States
Advanced Clinical Research Associates
Success Rates of the Procedure
Success of the procedure is a composite endpoint consisting of: Modified Observer's Assessment for Alertness/Sedation (MOAA/S) scores ≤4 on three consecutive measurements after administration of study drug AND completion of the endoscopy procedure AND no requirement for rescue sedative medication AND no requirement for manual or mechanical ventilation
Time frame: From start of study drug injection to patient discharge
Time to Fully Alert
Time to first of 3 consecutive MOAA/S scores of 5 after the last injection of double-blind study medication
Time frame: From last injection of double-blind study medication until fully alert criteria are reached
Time to Ready for Discharge
Time of the first of 3 consecutive Aldrete scores ≥ 9
Time frame: After the Last Injection of Double-Blind Study Medication AND after end of colonoscopy until first of 3 consecutive Aldrete scores ≥ 9
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Initial standardized dose plus supplemental doses as necessary.
Anaheim, California, United States
Miami Research Associates
South Miami, Florida, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Wake Research Associates
Raleigh, North Carolina, United States
Options Health Research
Tulsa, Oklahoma, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States