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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
Results First Posted : March 15, 2021
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories

Tracking Information
First Submitted Date  ICMJE July 10, 2014
First Posted Date  ICMJE July 15, 2014
Results First Submitted Date  ICMJE February 2, 2021
Results First Posted Date  ICMJE March 15, 2021
Last Update Posted Date March 15, 2021
Study Start Date  ICMJE June 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2021)
% of Subjects With Successful Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent) [ Time Frame: 2 days ]
Successful Preparation, defined as a colonoscopy rated as Excellent or Good by the blinded endoscopist. Poor: Large amounts of fecal residue, additional bowel preparation required; Fair: Enough feces even after washing and suctioning to prevent clear visualization of the entire colonic mucosa; Good: Feces and fluid requiring washing and suctioning, but still achieves clear visualization of the entire colonic mucosa; Excellent: No more than small bits of feces/fluid which can be suctioned easily; achieves clear visualization of the entire colonic mucosa
Original Primary Outcome Measures  ICMJE
 (submitted: July 14, 2014)
% of subjects with treatment emergent adverse events [ Time Frame: 30 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2014)
  • % of subjects with successful preparation rated by colonoscopist on a 4 point scale (1=poor to 4 = excellent) [ Time Frame: 2 days ]
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colonoscopy
Intervention  ICMJE
  • Drug: BLI800 - Dose 1
    BLI800 oral solution
    Other Name: BLI800
  • Drug: BLI800 - Dose 2
    BLI800 oral solution
    Other Name: BLI800
Study Arms  ICMJE
  • Experimental: BLI800 - Dose 1
    BLI800 oral solution
    Intervention: Drug: BLI800 - Dose 1
  • Experimental: BLI800 - Dose 2
    BLI800 oral solution
    Intervention: Drug: BLI800 - Dose 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2021)
29
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2014)
32
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02189850
Other Study ID Numbers  ICMJE BLI800-501
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Braintree Laboratories
Study Sponsor  ICMJE Braintree Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Braintree Laboratories
Verification Date February 2021

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