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Completed

NCT Number: NCT01928862

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

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

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Key information

Conditions

Need for Bowel Preparation

Age range

9 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Alabama, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prepopik® ½ Sachet x 2 (9-12 years)

Drug

Other names: Prepopik®

Prepopik® 1 Sachet x 2 (9-12 years)

Drug

Other names: Prepopik®

Oral polyethylene glycol (PEG) based preparation (9-12 years)

Drug

Prepopik® 1 Sachet x 2 (13-16 years)

Drug

Other names: Prepopik®

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

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: Prepopik PREA

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 27, 2013
Registry last updated
Apr 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.