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
386
multi-dose preparation for oral administration prior to colonoscopy
multi-dose preparation for oral administration prior to colonoscopy
Advanced Clinical Research Institute
Anaheim, California, United States
Advanced Clinical Research Institute
Orange, California, United States
Indiana University Medical Center
Indianapolis, Indiana, 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 days
Serum Chemistry Results (mEq/L)
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 (mg/dL)
Change from Baseline
Time frame: 2 days
Serum Chemistry Results (g/dL)
Change from Baseline
Time frame: 2 days
Serum Chemistry Results - Glomerular Filtration Rate
Change from Baseline
Time frame: 2 days
Hematology Results - Hemoglobin
Change from Baseline
Time frame: 2 days
Hematology Results (1000/MCL)
Change from Baseline
Time frame: 2 days
Hematology Results - Red Blood Cells
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Gastrointestinal Associates
Jackson, Mississippi, United States
Options Health Research
Tulsa, Oklahoma, United States
Northwest Gastroenterology Clinic
Portland, Oregon, United States
Franklin Gastroenterology
Franklin, Tennessee, United States
Memphis Gastroenterology Group
Germantown, Tennessee, United States
The Frist Clinic
Nashville, Tennessee, United States
Houston Medical Research Associates
Houston, Texas, United States
...and 2 more locations
Change from Baseline
Time frame: 2 days
Serum Chemistry Results (Osmolality)
Change from Baseline
Time frame: 2 days