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

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

Official Title
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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

Conditions
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Need for Bowel Preparation

Intervention / Treatment
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* Drug: Prepopik® ½ Sachet x 2 (9-12 years)
* Drug: Prepopik® 1 Sachet x 2 (9-12 years)
* Drug: Oral polyethylene glycol (PEG) based preparation (9-12 years)
* Drug: Prepopik® 1 Sachet x 2 (13-16 years)
* Drug: Oral polyethylene glycol (PEG) based preparation (13-16 years)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prepopik® ½ Sachet x 2 (9-12 years)<br>Prepopik® ½ Sachet x 2 (9-12 years) | Drug: Prepopik® ½ Sachet x 2 (9-12 years)<br> <br> * Other names: Prepopik®;|
| Experimental: Prepopik® 1 Sachet x 2 (9-12 years)<br>Prepopik® 1 Sachet x 2 (9-12 years) | Drug: Prepopik® 1 Sachet x 2 (9-12 years)<br> <br> * Other names: Prepopik®;|
| Active Comparator: Oral polyethylene glycol (PEG) based preparation (9-12 years)<br>Local standard of care | Drug: Oral polyethylene glycol (PEG) based preparation (9-12 years)<br> <br> |
| Experimental: Prepopik® 1 Sachet x 2 (13-16 years)<br>Prepopik® 1 Sachet x 2 (13-16 years) | Drug: Prepopik® 1 Sachet x 2 (13-16 years)<br> <br> * Other names: Prepopik®;|
| Active Comparator: Oral polyethylene glycol (PEG) based preparation (13-16 years)<br>Local standard of care | Drug: Oral polyethylene glycol (PEG) based preparation (13-16 years)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | On the day of colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 1 day of colonoscopy |