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A Safety and Efficacy Study of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy

This study is currently recruiting participants.
Verified August 2017 by Braintree Laboratories
Sponsor:
ClinicalTrials.gov Identifier:
NCT02819323
First Posted: June 30, 2016
Last Update Posted: August 10, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Braintree Laboratories
June 28, 2016
June 30, 2016
August 10, 2017
June 2016
January 2018   (Final data collection date for primary outcome measure)
% of subjects with successful bowel cleansing [ Time Frame: 2 days ]
Cleansing is rated by a blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent)
Same as current
Complete list of historical versions of study NCT02819323 on ClinicalTrials.gov Archive Site
  • Change in serum chemistry parameters [ Time Frame: up to 30 days ]
    Change in serum chemistry parameters from baseline to each follow up time point
  • % of subjects with treatment emergent adverse events [ Time Frame: up to 30 days ]
Same as current
Not Provided
Not Provided
 
A Safety and Efficacy Study of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
A Safety and Efficacy Study of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
The objective of this study is to compare the safety, tolerance and efficacy of BLI800 to a PEG based preparation prior to colonoscopy in adolescent patients.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Colonoscopy
  • Drug: PEG-ELS
    polyethylene glycol based bowel preparation
  • Drug: BLI800
    BLI800 bowel preparation
  • Experimental: BLI800 high dose
    BLI800 bowel preparation (high dose)
    Intervention: Drug: BLI800
  • Experimental: BLI800 low dose
    BLI800 bowel preparation (low dose)
    Intervention: Drug: BLI800
  • Active Comparator: PEG-ELS
    PEG based bowel preparation
    Intervention: Drug: PEG-ELS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
February 2018
January 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female between the ages of 12 to 16 (inclusive)
  2. Undergoing colonoscopy for routinely accepted indications, including (but not limited to):

    • Subjected inflammatory bowel disease (IBD) or IBD follow-up
    • Lower gastrointestinal bleeding
    • Suspected colitis (allergic or other)
    • Abdominal pain
    • Chronic diarrhea
    • Cancer surveillance
    • Anemia of unknown etiology
    • Abnormal endosonography or manometry
    • Evaluation of barium enema results
  3. If female, and of child-bearing potential, subject must use an acceptable form of birth control or remain abstinent for the duration of the study.
  4. Negative pregnancy test at screening, if applicable
  5. In the Investigator's judgment, caregiver is mentally competent to provide informed consent for their child to participate in the study.

Exclusion Criteria:

  1. Subjects with known or suspected ileus, impaction, severe ulcerative colitis, acute peritonitis, gastrointestinal obstruction, gastric retention (gastroparesis), bowel perforation, toxic colitis or megacolon.
  2. Subjects who had previous significant gastrointestinal surgeries.
  3. Subjects with increased risk of bowel perforation, including connective tissue disorders, toxic dilation of the bowel or recent bowel surgery.
  4. Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, uncorrected dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
  5. Subjects with bleeding disorders and/or impaired platelet function, or neutropenia.
  6. Subjects with a prior history of renal, liver or cardiac insufficiency (including congestive heart failure or other significant cardiac abnormality)
  7. Subjects with estimated glomerular filtration rate (GFR) below normal range (less than 70 ml/min/1.73m2)
  8. Subjects required to take any other oral medication within 3 hours of dosing until completion of both doses.
  9. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
  10. Subjects with tendency for nausea and/or vomiting, or that have known swallowing disorders.
  11. Subjects for whom intake of substances is likely to affect gastrointestinal motility or urinary flow rate.
  12. Subjects undergoing colonoscopy for foreign body removal and/or decompression.
  13. Subjects with an abnormal ECG result at Visit 1.
  14. Subjects who are pregnant or lactating, or intending to become pregnant during the study.
  15. Subjects of childbearing potential who refuse a pregnancy test.
  16. Subjects with a history of hypersensitivity to any preparation components.
  17. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures and history of major medical/psychiatric conditions that would compromise the safety of the study.
  18. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
  19. Subjects who withdraw consent before completion of Visit 1 procedures.
Sexes Eligible for Study: All
12 Years to 16 Years   (Child)
No
Contact: John McGowan 781-843-2202 jmcgowan@braintreelabs.com
United States
 
 
NCT02819323
BLI800-502
No
Not Provided
Plan to Share IPD: No
Braintree Laboratories
Braintree Laboratories
Not Provided
Study Director: John McGowan Braintree Laboratories, Inc.
Braintree Laboratories
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP