Colonoscopy
Conditions
Brief summary
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.
Interventions
Sponsors
Braintree Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Subjects With Successful Bowel Cleansing | 2 days | Cleansing is rated by a blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BLI800 High Dose BLI800 bowel preparation (high dose)
BLI800: BLI800 bowel preparation (6 oz) | 31 |
| BLI800 Low Dose BLI800 bowel preparation (low dose)
BLI800: BLI800 bowel preparation (4.5 oz) | 28 |
| PEG-ELS PEG based bowel preparation
PEG-ELS: polyethylene glycol based bowel preparation | 32 |
| Total | 91 |
Baseline characteristics
| Characteristic | BLI800 High Dose | BLI800 Low Dose | PEG-ELS | Total |
|---|---|---|---|---|
| Age, Continuous | 14.6 years STANDARD_DEVIATION 1.2 | 14.5 years STANDARD_DEVIATION 1.4 | 14.4 years STANDARD_DEVIATION 1.4 | 14.5 years STANDARD_DEVIATION 1.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 3 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 26 Participants | 29 Participants | 82 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 9 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 27 Participants | 24 Participants | 20 Participants | 71 Participants |
| Region of Enrollment United States | 31 participants | 28 participants | 32 participants | 91 participants |
| Sex: Female, Male Female | 19 Participants | 18 Participants | 15 Participants | 52 Participants |
| Sex: Female, Male Male | 12 Participants | 10 Participants | 17 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 28 | 0 / 32 |
| other Total, other adverse events | 29 / 31 | 26 / 28 | 29 / 32 |
| serious Total, serious adverse events | 0 / 31 | 0 / 28 | 1 / 32 |
Outcome results
Primary
Number and Percentage of Subjects With Successful Bowel Cleansing
Cleansing is rated by a blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent)
Time frame: 2 days
Population: Efficacy population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BLI800 High Dose | Number and Percentage of Subjects With Successful Bowel Cleansing | 25 Participants |
| BLI800 Low Dose | Number and Percentage of Subjects With Successful Bowel Cleansing | 22 Participants |
| PEG-ELS | Number and Percentage of Subjects With Successful Bowel Cleansing | 19 Participants |
p-value: 0.003Cochran-Mantel-Haenszel
p-value: 0.003Cochran-Mantel-Haenszel
p-value: 0.046Cochran-Mantel-Haenszel
p-value: 0.089Cochran-Mantel-Haenszel