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

Completed · Phase 1/Phase 2

Conditions studied: Need for Bowel Preparation

In brief

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

Key facts

Study ID

NCT01928862

Run by

Ferring Pharmaceuticals

People needed

78

Starts

2014-06-03

Expected to finish

2017-03-16

Last updated by the study team

2018-04-23

Who can join

Age: 9 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• University California San Diego - Rady's Children's Hospital — San Diego, California, United States
• IU Medical Center / Riley Hospital — Indianapolis, Indiana, United States
• John Hopkins — Baltimore, Maryland, United States
• Stony Brook Children's — Stony Brook, New York, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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