Efficacy and Safety of Prepopik® in Children for Overall Colon Cleansing in Preparation for Colonoscopy

A Randomized, Assessor-Blind, Multicenter, Dose-Ranging Study Comparing the Safety and Efficacy of Prepopik® Versus Polyethylene Glycol Preparation (Local Standard of Care) in Children Aged 9 Years to 16 Years

To study the efficacy and safety of Prepopik® in children aged 9 to 16 years for overall colon cleansing in preparation of colonoscopy

Inclusion Criteria:

• Male or female, aged 9 years to 16 years, inclusive, being scheduled to undergo elective colonoscopy
• Subjects must have had 3 or more spontaneous bowel movements per week for 1 month prior to the colonoscopy
• Female subjects of childbearing potential must undergo a pregnancy test at screening and again at randomization

Exclusion Criteria:

• Acute surgical abdominal conditions (e.g., acute obstruction or perforation)
• Hospitalized for inflammatory bowel disease
• Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery, or prior endoscopic surgical procedures
• Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudo obstruction, hypomotility syndrome, colon resection)
• Ascites
• Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)
• Upper gastrointestinal surgery (gastric resection, gastric banding, gastric bypass)
• Significant cardiovascular disease as determined by the investigator
• If subject has a history of renal insufficiency, serum creatinine and potassium must be within normal limits
• Any clinically significant laboratory value at screening, including pre- existing electrolyte abnormality, based on clinical history
• Hypersensitivity to active ingredients