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

Phase 1

Completed

Conditions: Need for Bowel Preparation

Interventions: Drug: Oral polyethylene glycol (PEG) based preparation (13-16 years)
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)

Registration Number: NCT01928862

Lead Sponsor: Ferring Pharmaceuticals

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 78

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral polyethylene glycol (PEG) based preparation (13-16 years)	Oral polyethylene glycol (PEG) based preparation (13-16 years)	Local standard of care
Prepopik® ½ Sachet x 2 (9-12 years)	Prepopik® ½ Sachet x 2 (9-12 years)	Prepopik® ½ Sachet x 2 (9-12 years)
Prepopik® 1 Sachet x 2 (9-12 years)	Prepopik® 1 Sachet x 2 (9-12 years)	Prepopik® 1 Sachet x 2 (9-12 years)
Oral polyethylene glycol (PEG) based preparation (9-12 years)	Oral polyethylene glycol (PEG) based preparation (9-12 years)	Local standard of care
Prepopik® 1 Sachet x 2 (13-16 years)	Prepopik® 1 Sachet x 2 (13-16 years)	Prepopik® 1 Sachet x 2 (13-16 years)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Defined by "Excellent" or "Good" in the Aronchick Scale	On the day of colonoscopy	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Took the Assigned Dose for Colon Cleansing	Approx. 1 day (From the day before colonoscopy to the day of colonoscopy)	The proportion of participants who took the assigned dose of Prepopik® was assessed.
Number of Participants in Each Category of the "Subject's Tolerability and Satisfaction Questionaire"	1 day of colonoscopy	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.
Number of Participants With Adverse Events	Up to 33 days after colonoscopy	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.
Number of Participants With Abnormal Findings in Laboratory Tests	From up to 42 days prior to colonoscopy, at the day of colonoscopy, and up to 7 days post colonoscopy	Proportion of participants with abnormal findings in laboratory tests are presented.
Number of Participants With Abnormal Findings in Physical Examination	From up to 42 days prior to colonoscopy, on the day of randomization, and at the day of colonoscopy	Complete physical examination was conducted at screening and directed physical examinations at other time-points. Directed physical examinations are presented.

Trial Locations

Locations (9): University California San Diego - Rady's Children's Hospital
🇺🇸
San Diego, California, United States
IU Medical Center / Riley Hospital
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Indianapolis, Indiana, United States
John Hopkins
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Baltimore, Maryland, United States
Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
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Pittsburgh, Pennsylvania, United States
University of Alabama
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Birmingham, Alabama, United States
Vanderbilt University Medical Center
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Nashville, Tennessee, United States
Nationwide Children's Hospital
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Columbus, Ohio, United States
Stony Brook Children's
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Stony Brook, New York, United States