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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02189850
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories

Brief Summary:
The purpose o this study is to evaluate the safety, tolerance and efficacy of BLI800 as a bowel preparation prior to colonoscopy in pediatric patients.

Condition or disease Intervention/treatment Phase
Colonoscopy Drug: BLI800 - Dose 1 Drug: BLI800 - Dose 2 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2014
Actual Primary Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: BLI800 - Dose 1
BLI800 oral solution
Drug: BLI800 - Dose 1
BLI800 oral solution
Other Name: BLI800

Experimental: BLI800 - Dose 2
BLI800 oral solution
Drug: BLI800 - Dose 2
BLI800 oral solution
Other Name: BLI800




Primary Outcome Measures :
  1. % of subjects with treatment emergent adverse events [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. % of subjects with successful preparation rated by colonoscopist on a 4 point scale (1=poor to 4 = excellent) [ Time Frame: 2 days ]
  2. Change in serum chemistry parameters [ Time Frame: 9 days ]
    Change in serum chemistry parameters from screening (ALT, AST, bicarbonate, total bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, eGFR, GGT, HCG, magnesium, phosphorus, potassium, sodium, anion gap, total protein, uric acid and osmolality).



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Male or female between the ages of 12 to 17
  • Weight more than 40kg
  • Undergoing colonoscopy for routinely accepted indications
  • 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.
  • Negative pregnancy test at screening, if applicable
  • In the Investigator's judgment, caregiver is mentally competent to provide informed consent for their child to participate in the study.

Exclusion Criteria:

  • Subjects with known or suspected ileus, impaction, severe ulcerative colitis, acute peritonitis, gastrointestinal obstruction, gastric retention (gastroparesis), bowel perforation, toxic colitis or megacolon.
  • Subjects who had previous significant gastrointestinal surgeries.
  • Subjects with increased risk of bowel perforation, including connective tissue disorders, toxic dilation of the bowel or recent bowel surgery.
  • Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results
  • Subjects with bleeding disorders and/or impaired platelet function, or neutropenia.
  • Subjects with a prior history of renal, liver or cardiac insufficiency
  • Subjects required to take any other oral medication within 3 hours of dosing until completion of both doses.
  • Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
  • Subjects with tendency for nausea and/or vomiting, or that have known swallowing disorders.
  • Subjects for whom intake of substances is likely to affect gastrointestinal motility or urinary flow rate.
  • Subjects undergoing colonoscopy for foreign body removal and/or decompression.

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): NCT02189850


Locations
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United States, Arkansas
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States
United States, Georgia
Children's Center for Digestive Health Care
Atlanta, Georgia, United States
United States, Louisiana
Delta Research Partners
Bastrop, Louisiana, United States
United States, Mississippi
Gastrointestinal Associates
Jackson, Mississippi, United States
United States, New York
University of Buffalo Pediatric Associates
Buffalo, New York, United States
Sponsors and Collaborators
Braintree Laboratories
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Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT02189850    
Other Study ID Numbers: BLI800-501
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016
Keywords provided by Braintree Laboratories:
colonoscopy
pediatric