Trial record 2 of 4 for:    colon cleansing AND Ferring

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Ferring Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01928862
First received: August 19, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Need for Bowel Preparation
Drug: Prepopik™ ½ sachet (9-12 years)
Drug: Prepopik™ 1 sachet (9-12 years)
Drug: Oral polyethylene glycol (PEG) based preparation (9-12 years)
Drug: Prepopik™ 1 sachet (13-16 years)
Drug: Oral polyethylene glycol (PEG) based preparation (13-16 years)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Number of subjects defined by "excellent" or "good" in the Aronchick Scale [ Time Frame: 1 day of colonoscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Up to 33 days after colonoscopy ] [ Designated as safety issue: Yes ]
  • Incidence of abnormal findings in laboratory tests [ Time Frame: Up to 7 days post colonoscopy ] [ Designated as safety issue: Yes ]
  • Incidence of abnormal findings in physical exams [ Time Frame: From up to 21 days prior to colonoscopy and at the day of colonoscopy ] [ Designated as safety issue: Yes ]
  • Number of subjects who took the assigned dose for colon cleansing [ Time Frame: approx. 1 day (From the day before colonoscopy to the day of colonoscopy) ] [ Designated as safety issue: No ]
  • Frequency of each category of the "Subject's Tolerability and Satisfaction Questionaire" [ Time Frame: 1 day of colonoscopy ] [ Designated as safety issue: No ]
  • Pharmacokinetic (PK) assessment: Cmax (maximum concentration of drug in the blood) [ Time Frame: Up to 7 days after colonoscopy ] [ Designated as safety issue: No ]
    For PK sampling 5 subjects per treatment group will be assessed

  • PK assessment: Tmax (time when maximum concentration of drug in the blood is achieved) [ Time Frame: Up to 7 days after colonoscopy ] [ Designated as safety issue: No ]
    For PK sampling 5 subjects per treatment group will be assessed

  • PK assessment: AUC (area under the curve correlates with the total amount of drug exposure in the blood) [ Time Frame: Up to 7 days after colonoscopy ] [ Designated as safety issue: No ]
    For PK sampling approximately 5 subjects per treatment group will be assessed


Estimated Enrollment: 75
Study Start Date: March 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prepopik™ ½ sachet (9-12 years)
Prepopik™ ½ sachet (9-12 years)
Drug: Prepopik™ ½ sachet (9-12 years)
Other Name: Prepopik™
Experimental: Prepopik™ 1 sachet (9-12 years)
Prepopik™ 1 sachet (9-12 years)
Drug: Prepopik™ 1 sachet (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 (13-16 years)
Prepopik™ 1 sachet (13-16 years)
Drug: Prepopik™ 1 sachet (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)

  Eligibility

Ages Eligible for Study:   9 Years to 16 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01928862

Contacts
Contact: Clinical Development Support DK0-Disclosure@ferring.com

Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States
United States, Indiana
IU Medical Center / Riley Hospital Recruiting
Indianapolis, Indiana, United States
United States, Maryland
John Hopkins Recruiting
Baltimore, Maryland, United States
United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States
United States, New York
Stony Brook Children's Recruiting
Stony Brook, New York, United States
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States
United States, Pennsylvania
Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01928862     History of Changes
Other Study ID Numbers: 000103
Study First Received: August 19, 2013
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 21, 2014