To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
308
multi dose formulation (tablet/solution) for oral administration prior to colonoscopy
multi dose preparation (tablet/solution) for oral administration prior to colonoscopy
Advanced Clinical Research Institute
Anaheim, California, United States
Advanced Clinical Research Institute
Orange, California, United States
Medical Associates Research Group
San Diego, California, United States
United Medical Research
New Smyrna Beach, Florida, United States
Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale
Cleansing was scored with a four point scale used in previous bowel cleansing studies where 4 = "excellent" (no more than small bits of adherent feces/fluid); 3 = "good" (small amounts of feces or fluid not interfering with the exam); 2 = "fair" (enough feces or fluid to prevent a completely reliable exam); 1 = "poor" (large amounts of fecal residue requiring additional cleansing). For the primary efficacy endpoint (preparation success), grades of 4 and 3 were considered a "success" and grades of 2 or 1 were considered a "failure".
Time frame: during colonoscopy
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Maryland Digestive Disease Research
Laurel, Maryland, United States
Franklin Gastroenterology
Franklin, Tennessee, United States