Methods
colorectal cancer, the bowel preparation
ADVERSE EVENTS, COLORECTAL CANCER, COLON
This was an open-label, active-controlled, sequential-cohort study in adult patients undergoing colonoscopy for colorectal cancer screening and surveillance or for diagnostic purposes. This study was conducted at 4 U.S. endoscopy centers and approved by Aspire, Institutional Review Board and registered on A screening visit was performed for eligible patients within 30 days prior to their scheduled colonoscopy which included routine blood chemistry. In this adaptive design study conducted over a two-year period, twenty subjects were planned to take the PEG-SD control, with various experimental formulations concurrently and subsequently evaluated (not discussed here) with 40 subjects ultimately planned to take the FPSS to-be-marketed formulation. Preparation administration was not randomized.On the day prior to colonoscopy, subjects were allowed a low residue breakfast followed by clear liquids until the colonoscopy was completed the following day. Both preparations were administered using the American College of Gastroenterology recommended split-dose (PM/AM) regimen. Subjects assigned to FPSS reconstituted the one-liter dose with water on the evening prior to colonoscopy and consumed 8 oz of solution every 15 min until complete. A second one-liter dose was taken the morning of colonoscopy. FPSS subjects drank an additional 16oz of water following each preparation dose. Subjects assigned to PEG-SD received two 5 mg over-the-counter bisacodyl laxative tablets, two 32-ounce bottles of Lemon-Lime flavored sports drink (Gatorade; PepsiCo, Inc., Chicago, IL, USA), and two 119 g bottles of Polyethylene glycol 3350 (PEG 3350). Subjects were instructed to take the bisacodyl at approximately 3PM on the day prior to colonoscopy. Subjects then mixed one bottle of PEG 3350 with one bottle of Gatorade and consumed 8 oz every 15 min until complete, along with additional water. A second one-liter dose was taken the morning of colonoscopy.Subjects returned to the clinic the day of colonoscopy. Patients were queried for occurrence of adverse events, given a physical examination, and a blood sample was taken for routine chemistry. Colonoscopies were performed by unblinded endoscopists according to the site’s standard procedures. Colon cleanliness was assessed following completion of the exam using a 4-point scale (Table 
Bowel Preparation Cleansing ScalePrior to their procedure, all patients were asked to complete a questionnaire which included questions related to preparation satisfaction, including: How easy or difficult was it to consume the study preparation (Very Difficult to Very Easy)?; Please describe your overall experience with the bowel preparation (Bad to Excellent); How did this bowel preparation experience compare to your prior experiences (Worse to Better)?; Would you ask your doctor for this preparation again if you need another colonoscopy in the future? (Yes or No); Would you refuse the same preparation again if it were to be prescribed to you in the future? (Yes or No). In addition, FPSS patients were asked the following: Please rate your feelings about the aftertaste of the preparation (Very Pleasant to Very Unpleasant), and; To what degree do you believe the product tastes similar to a sports drink? (Agree Extremely to Disagree Extremely).