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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01928862
Recruitment Status : Completed
First Posted : August 27, 2013
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Need for Bowel Preparation 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) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 3, 2014
Actual Primary Completion Date : February 15, 2017
Actual Study Completion Date : March 16, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prepopik® ½ Sachet x 2 (9-12 years)
Prepopik® ½ Sachet x 2 (9-12 years)
Drug: Prepopik® ½ Sachet x 2 (9-12 years)
Other Name: Prepopik®

Experimental: Prepopik® 1 Sachet x 2 (9-12 years)
Prepopik® 1 Sachet x 2 (9-12 years)
Drug: Prepopik® 1 Sachet x 2 (9-12 years)
Other Name: 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)
Prepopik® 1 Sachet x 2 (13-16 years)
Drug: Prepopik® 1 Sachet x 2 (13-16 years)
Other Name: 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)



Primary Outcome Measures :
  1. Percentage of Participants Defined by "Excellent" or "Good" in the Aronchick Scale [ Time Frame: 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 :
  1. Number of Participants With Adverse Events [ Time Frame: 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.

  2. Number of Participants With Abnormal Findings in Laboratory Tests [ Time Frame: 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.

  3. Number of Participants With Abnormal Findings in Physical Examination [ Time Frame: 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.

  4. Number of Participants Who Took the Assigned Dose for Colon Cleansing [ Time Frame: 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.

  5. Number of Participants in Each Category of the "Subject's Tolerability and Satisfaction Questionaire" [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928862


Locations
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United States, Alabama
University of Alabama
Birmingham, Alabama, United States
United States, California
University California San Diego - Rady's Children's Hospital
San Diego, California, United States
United States, Indiana
IU Medical Center / Riley Hospital
Indianapolis, Indiana, United States
United States, Maryland
John Hopkins
Baltimore, Maryland, United States
United States, New York
Stony Brook Children's
Stony Brook, New York, United States
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
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Study Director: Clinical Development Support Ferring Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Ferring Pharmaceuticals:
Study Protocol  [PDF] July 28, 2014
Statistical Analysis Plan  [PDF] February 16, 2017

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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01928862    
Other Study ID Numbers: 000103
First Posted: August 27, 2013    Key Record Dates
Results First Posted: April 23, 2018
Last Update Posted: April 23, 2018
Last Verified: March 2018