To study the efficacy and safety of Prepopik® in children aged 9 to 16 years for overall colon cleansing in preparation of colonoscopy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
78
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
Percentage of Participants Defined by "Excellent" or "Good" in the Aronchick Scale
Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (\>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (\>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (\>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (\<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed). The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.
Time frame: On the day of colonoscopy
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant taking part in a clinical trial. Proportion of participants with AE are presented.
Time frame: Up to 33 days after colonoscopy
Number of Participants With Abnormal Findings in Laboratory Tests
Proportion of participants with abnormal findings in laboratory tests are presented.
Time frame: From up to 42 days prior to colonoscopy, at the day of colonoscopy, and up to 7 days post colonoscopy
Number of Participants With Abnormal Findings in Physical Examination
Complete physical examination was conducted at screening and directed physical examinations at other time-points. Directed physical examinations are presented.
Time frame: From up to 42 days prior to colonoscopy, on the day of randomization, and at the day of colonoscopy
Number of Participants Who Took the Assigned Dose for Colon Cleansing
The proportion of participants who took the assigned dose of Prepopik® was assessed.
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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
Time frame: Approx. 1 day (From the day before colonoscopy to the day of colonoscopy)
Number of Participants in Each Category of the "Subject's Tolerability and Satisfaction Questionaire"
Subject's Tolerability and Satisfaction Questionnaire consists of three questions. Question (Q)1 was "How easy was it to drink the bowel cleanout medicine?" and Q2 was "How did the bowel cleanout medicine taste?". Q3 had five subparts namely: 1. "How often did your tummy hurt since you started the medicine?" and 2. "How often did you feel fullness in your tummy, since you started the cleanout?" and 3. "How often did you wake up last night" and 4. "How often did you feel sick to your stomach (nausea) since you started the cleanout?' and 5. "How much were you bothered by going to the washroom since you started the cleanout?" Satisfactory was defined as a response of 1 (Very Easy) or 2 (Easy) on Q1 and a response of 1 (Very Well) or 2 (Well) on Q2. Tolerable was defined as a response of 1 (Never) or 2 (Rarely) to the five subparts specified in Q3.
Time frame: 1 day of colonoscopy