This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
394
multi-dose preparation for oral administration prior to colonoscopy
multi-dose preparation for oral administration prior to colonoscopy
University of South Alabama
Mobile, Alabama, United States
Jupiter Research
Jupiter, Florida, United States
Miami Research Associates
Miami, Florida, United States
Efficacy - Preparation Quality Using a 4 Point Scale
Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent"
Time frame: 2-day
Serum Chemistry Results (mg/dL)
Change from Baseline
Time frame: 2 days
Hematology Results (%)
Change from Baseline
Time frame: 2 days
Serum Chemistry Results (U/L)
Change from Baseline
Time frame: 2 days
Serum Chemistry Results (mEq/L)
Change from Baseline
Time frame: 2 days
Serum Chemistry Results (g/dL)
Change from Baseline
Time frame: 2 days
Serum Chemistry Results (GFR)
Change from Baseline
Time frame: 2 days
Hematology Results (1000/MCL)
Change from Baseline
Time frame: 2 days
Hematology Results - Hemoglobin
Change from Baseline
Time frame: 2 days
Hematology Results - Red Blood Cells
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United Medical Research
New Smyrna Beach, Florida, United States
Atlanta Gastroenterology Associates
Roswell, Georgia, United States
Delta Research Partners
Monroe, Louisiana, United States
Maryland Digestive Disease Research
Laurel, Maryland, United States
Long Island GI Research Group
Great Neck, New York, United States
Carolina Digestive Health Associates
Harrisburg, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
...and 2 more locations
Change from Baseline
Time frame: 2 days
Serum Chemistry Results (Osmolality)
Change from Baseline
Time frame: 2 days