Clinical trial NCT01928862: Efficacy and Safety of Prepopik® in Children for Overall Colon Cleansing in Preparation for Colonoscopy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Need for Bowel Preparation
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-08-27
Enrollment: 78
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Percentage of Participants Defined by "Excellent" or "Good" in the Aronchick Scale
timeFrame: On the day of colonoscopy
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Up to 33 days after colonoscopy
measure: Number of Participants With Abnormal Findings in Laboratory Tests
timeFrame: From up to 42 days prior to colonoscopy, at the day of colonoscopy, and up to 7 days post colonoscopy
measure: Number of Participants With Abnormal Findings in Physical Examination
timeFrame: From up to 42 days prior to colonoscopy, on the day of randomization, and at the day of colonoscopy
measure: Number of Participants Who Took the Assigned Dose for Colon Cleansing
timeFrame: Approx. 1 day (From the day before colonoscopy to the day of colonoscopy)
measure: Number of Participants in Each Category of the "Subject's Tolerability and Satisfaction Questionaire"
timeFrame: 1 day of colonoscopy
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: San Diego
country: United States
facility: University California San Diego - Rady's Children's Hospital
state: California
city: Indianapolis
country: United States
facility: IU Medical Center / Riley Hospital
state: Indiana
city: Baltimore
country: United States
facility: John Hopkins
state: Maryland
city: Stony Brook
country: United States
facility: Stony Brook Children's
state: New York
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: