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

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

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

Study Overview

• Status: Completed
• Conditions: Need for Bowel Preparation
• Intervention / Treatment: 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)

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2014
• Primary Completion (Actual): February 15, 2017
• Study Completion (Actual): March 16, 2017

Study Registration Dates

• First Submitted: August 19, 2013
• First Submitted That Met QC Criteria: August 26, 2013
• First Posted (Estimate): August 27, 2013

Study Record Updates

• Last Update Posted (Actual): April 23, 2018
• Last Update Submitted That Met QC Criteria: March 23, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 000103