Colonoscopy
Conditions
Brief summary
The objective of this study is to evaluate the safety and efficacy of BLI4900 as a bowel preparation prior to colonoscopy in adult patients.
Interventions
DRUGBLI4900
BLI4900 Bowel Preparation
DRUGPEG Control
Polyethylene glycol-based bowel preparation
Sponsors
Braintree Laboratories
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication. * 18 to 85 years of age (inclusive). * If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse). * Negative urine pregnancy test at screening, if applicable. * In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study.
Exclusion criteria
* Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon. * Subjects with ongoing severe, acute inflammatory bowel disease. * Subjects who had previous significant gastrointestinal surgeries. * Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results. * Subjects with uncontrolled hypertension (systolic blood pressure \> 170 mmHg and diastolic blood pressure \> 100 mmHg). * Subjects with severe renal insufficiency (GFR \< 30 mL/min/1.73m2). * Subjects with known severe hepatic insufficiency (Child Pugh C). * Subjects with cardiac insufficiency (NYHA Functional Classifications 3 or 4). * Subjects undergoing insulin therapy for any indication. * Subjects with impaired consciousness that predisposes them to pulmonary aspiration. * Subjects undergoing colonoscopy for foreign body removal and/or decompression. * Subjects who are pregnant or lactating, or intending to become pregnant during the study. * Subjects of childbearing potential who refuse a pregnancy test. * Subjects allergic to any preparation components. * Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures. * Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days. * Subjects who withdraw consent before completion of Visit 1 procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % of Subjects With Successful Bowel Preparation | Day of colonoscopy | % of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BLI4900-3 Formulation 3 | 21 |
| BLI4900-5 Formulation 5 | 40 |
| BLI4900-6 Formulation 6 | 40 |
| PEG-SD Polyethylene glycol 3350 mixed with sports drink (plus bisacodyl) | 19 |
| Total | 120 |
Baseline characteristics
| Characteristic | BLI4900-3 | Total | PEG-SD | BLI4900-6 | BLI4900-5 |
|---|---|---|---|---|---|
| Age, Continuous | 54.8 years STANDARD_DEVIATION 11.1 | 55.2 years STANDARD_DEVIATION 12 | 49.7 years STANDARD_DEVIATION 15.7 | 58.7 years STANDARD_DEVIATION 10.2 | 54.5 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 28 Participants | 7 Participants | 15 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 92 Participants | 12 Participants | 25 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 14 Participants | 4 Participants | 6 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 1 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 4 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 98 Participants | 14 Participants | 29 Participants | 38 Participants |
| Region of Enrollment United States | 21 Participants | 120 Participants | 19 Participants | 40 Participants | 40 Participants |
| Sex: Female, Male Female | 10 Participants | 66 Participants | 12 Participants | 24 Participants | 20 Participants |
| Sex: Female, Male Male | 11 Participants | 54 Participants | 7 Participants | 16 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 40 | 0 / 41 | 0 / 19 |
| other Total, other adverse events | 13 / 21 | 31 / 40 | 13 / 41 | 14 / 19 |
| serious Total, serious adverse events | 0 / 21 | 0 / 40 | 0 / 41 | 1 / 19 |
Outcome results
Primary
% of Subjects With Successful Bowel Preparation
% of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent)
Time frame: Day of colonoscopy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BLI4900-3 | % of Subjects With Successful Bowel Preparation | 17 Participants |
| BLI4900-5 | % of Subjects With Successful Bowel Preparation | 37 Participants |
| BLI4900-6 | % of Subjects With Successful Bowel Preparation | 37 Participants |
| PEG-SD | % of Subjects With Successful Bowel Preparation | 16 Participants |