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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
  Purpose
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.

Condition Intervention Phase
Colonoscopy Drug: PEG-ELS Drug: BLI800 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Study of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy

Resource links provided by NLM:


Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:
  • % 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)


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: June 2016
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BLI800 high dose
BLI800 bowel preparation (high dose)
Drug: BLI800
BLI800 bowel preparation
Experimental: BLI800 low dose
BLI800 bowel preparation (low dose)
Drug: BLI800
BLI800 bowel preparation
Active Comparator: PEG-ELS
PEG based bowel preparation
Drug: PEG-ELS
polyethylene glycol based bowel preparation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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): NCT02819323


Contacts
Contact: John McGowan 781-843-2202 jmcgowan@braintreelabs.com

  Show 27 Study Locations
Sponsors and Collaborators
Braintree Laboratories
Investigators
Study Director: John McGowan Braintree Laboratories, Inc.
  More Information

Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT02819323     History of Changes
Other Study ID Numbers: BLI800-502
First Submitted: June 28, 2016
First Posted: June 30, 2016
Last Update Posted: August 10, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No