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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

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, Learn About Clinical Studies.


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

  Hide Study Locations
Locations
United States, Alabama
Braintree Research Site 27 Recruiting
Mobile, Alabama, United States, 36582
United States, Arizona
Braintree Research Site 30 Recruiting
Tucson, Arizona, United States, 85724
United States, California
Braintree Research Site 23 Recruiting
Orange, California, United States, 92868
Braintree Research Site 16 Recruiting
San Francisco, California, United States, 94158
United States, Florida
Braintree Research Site 5 Terminated
Gainesville, Florida, United States, 32610
Braintree Research Site 24 Recruiting
Jacksonville, Florida, United States, 32207
Braintree Research Site 21 Recruiting
Orlando, Florida, United States, 32806
United States, Georgia
Braintree Research Site 2 Recruiting
Atlanta, Georgia, United States, 30342
United States, Illinois
Braintree Research Site 13 Not yet recruiting
Chicago, Illinois, United States, 60611
Braintree Research Site 3 Recruiting
Park Ridge, Illinois, United States, 60068
United States, Indiana
Braintree Research Site 26 Recruiting
Indianapolis, Indiana, United States, 46202
United States, Minnesota
Braintree Research Site 25 Recruiting
Minneapolis, Minnesota, United States, 55454
Braintree Research Site 18 Recruiting
Rochester, Minnesota, United States, 55905
United States, Mississippi
Braintree Research Site 1 Recruiting
Flowood, Mississippi, United States, 39232
United States, New York
Braintree Research Site 9 Recruiting
Buffalo, New York, United States, 14222
Braintree Research Site 28 Not yet recruiting
New York, New York, United States, 10021
Braintree Research Site 19 Recruiting
New York, New York, United States, 10032
Braintree Research Site 32 Recruiting
The Bronx, New York, United States, 10467
United States, Pennsylvania
Braintree Research Site 6 Recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Braintree Research Site 20 Recruiting
Memphis, Tennessee, United States, 38103
United States, Texas
Braintree Research Site 34 Recruiting
Plano, Texas, United States, 75093
United States, Utah
Braintree Research Site 22 Recruiting
Salt Lake City, Utah, United States, 84118
United States, Vermont
Braintree Research Site 10 Recruiting
Burlington, Vermont, United States, 05401
United States, Virginia
Braintree Research Site 17 Recruiting
Norfolk, Virginia, United States, 23507
Braintree Research Site 4 Recruiting
Roanoke, Virginia, United States, 24013
United States, Washington
Braintree Research Site 11 Recruiting
Seattle, Washington, United States, 98105
United States, Wisconsin
Braintree Research Site 14 Recruiting
Milwaukee, Wisconsin, United States, 53226
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