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

• Status: Completed
• Trial end date: 2017-03-16
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals

Criteria

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