Adults

The colon cleansing efficacy of SUPREP Bowel Prep Kit was evaluated in a randomized, single-blind, active-controlled, multicenter study in adult patients scheduled to have a colonoscopy. There were 363 adult patients included in the efficacy analysis. Patients ranged in age from 20 to 84 years (mean age 55 years) and 54% were female. Race distribution was 86% Caucasian, 9% African-American, and 5% other.

Patients were randomized to one of the following two colon preparation regimens: SUPREP Bowel Prep Kit or a marketed polyethylene glycol (PEG) plus electrolytes bowel preparation. In the Study SUPREP Bowel Prep Kit was administered as a split-dose (two-day) regimen. The PEG bowel prep was also given as a split-dose preparation according to its labeled instructions. Patients receiving SUPREP Bowel Prep Kit were limited to a light breakfast followed by clear liquids on the day prior to the day of colonoscopy; patients receiving the PEG bowel prep were allowed to have a normal breakfast and a light lunch, followed by clear liquids.

The primary efficacy endpoint was the proportion of patients with successful colon cleansing as assessed by the colonoscopists, who were not informed about the type of preparation received, as shown in Table 3. In the study, no clinically or statistically significant differences were seen between the group treated with SUPREP Bowel Prep Kit and the group treated with the PEG bowel prep.

Pediatric Patients 12 Years to 16 Years of Age

SUPREP Bowel Prep Kit was evaluated for colon cleansing in a randomized, single-blind, multicenter, doseranging, active-controlled study in 89 pediatric patients 12 years to 16 years of age. The majority of patients were female (57%), white (78%), and of non-Hispanic or non-Latino ethnicity (91%). The mean age was 14 years. The median body weight was 60 kg (range 32 to 155 kg).

Patients were randomized to SUPREP Bowel Prep Kit (two 6-ounce doses), SUPREP Bowel Prep Kit (two 4.5-ounce doses) or oral PEG solution. SUPREP Bowel Prep Kit (two 6-ounce doses) did not demonstrate additional treatment benefit and more patients reported gastrointestinal adverse reactions compared to SUPREP Bowel Prep Kit (two 4.5-ounce doses); therefore, SUPREP Bowel Prep Kit (two 6-ounce doses) is not recommended for pediatric patients 12 years of age and older [see Dosage and Administration ( 2.4)] . 

Patients in the SUPREP Bowel Prep Kit (two 4.5-ounce doses) group took the preparation in a “split-dose” regimen, where the first dose was taken the evening before colonoscopy, with the second dose taken the morning of the exam. Patients in the control group took the preparation according to its approved labeling on the evening before colonoscopy.

Patients in the SUPREP Bowel Prep Kit group (two 4.5-ounce doses) were allowed to have a light breakfast on the day before colonoscopy, followed by clear liquids until the colonoscopy is completed the following day. Patients in the control group subjects were permitted only clear liquids on the day prior to colonoscopy until completion of the colonoscopy the following day.

The primary efficacy endpoint was the proportion of patients with successful colon cleansing as assessed by the colonoscopists, who were not informed about the type of preparation received.

The percentage of responders and the associated 95% confidence intervals for the SUPREP Bowel Prep Kit (two 4.5-ounce doses) and Oral PEG solution are shown in Table 4. Efficacy was similar between patients who weighed 65 kg or more (n=12) and those patients who weighed less than 65 kg (n=15) in the SUPREP Bowel Prep Kit (two 4.5-ounce doses) arm.