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