Colonoscopy
Conditions
Keywords
colonoscopy, pediatric
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.
Interventions
DRUGBLI800 - Dose 1
BLI800 oral solution
DRUGBLI800 - Dose 2
BLI800 oral solution
Sponsors
Braintree Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % of Subjects With Successful Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BLI800 - Dose 1 BLI800 oral solution
BLI800 - Dose 1: BLI800 oral solution (6 oz) | 16 |
| BLI800 - Dose 2 BLI800 oral solution
BLI800 - Dose 2: BLI800 oral solution (4.5 oz) | 13 |
| Total | 29 |
Baseline characteristics
| Characteristic | BLI800 - Dose 1 | BLI800 - Dose 2 | Total |
|---|---|---|---|
| Age, Continuous | 15.2 years STANDARD_DEVIATION 1.2 | 15.8 years STANDARD_DEVIATION 1.4 | 15.5 years STANDARD_DEVIATION 1.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 13 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Puburtal Staging I | 0 Participants | 0 Participants | 0 Participants |
| Puburtal Staging II | 0 Participants | 1 Participants | 1 Participants |
| Puburtal Staging III | 1 Participants | 0 Participants | 1 Participants |
| Puburtal Staging IV | 3 Participants | 1 Participants | 4 Participants |
| Puburtal Staging V | 12 Participants | 11 Participants | 23 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 10 Participants | 22 Participants |
| Region of Enrollment United States | 16 participants | 13 participants | 29 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 9 Participants | 5 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 13 |
| other Total, other adverse events | 13 / 16 | 12 / 13 |
| serious Total, serious adverse events | 0 / 16 | 0 / 13 |
Outcome results
Primary
% of Subjects With Successful Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent)
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
Time frame: 2 days
Population: Efficacy population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BLI800 - Dose 1 | % of Subjects With Successful Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent) | 13 Participants |
| BLI800 - Dose 2 | % of Subjects With Successful Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent) | 10 Participants |
p-value: 0.923Cochran-Mantel-Haenszel