Colonoscopy
Conditions
Brief summary
The objective of this study is to compare the safety and efficacy of BLI4700 bowel preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.
Interventions
DRUGBLI4700
Oral bowel preparation
DRUGMagnesium bowel preparation
Oral bowel preparation
Sponsors
Braintree Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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 serum 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, gastrointestinal obstruction, gastroparesis, 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 taking diuretics, anti-hypertensive medications, including angiotensin converting enzyme (ACE) inhibitors and Angiotensin II receptor blockers (ARBs), or chronic NSAIDs, that have not been stable for 30 days. NSAID use for occasional pain is not exclusionary. * Subjects with uncontrolled hypertension (systolic blood pressure \> 170 mmHg and diastolic blood pressure \> 100 mmHg). * Subjects taking antibiotics within 7 days of colonoscopy. * 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 with an abnormal and clinically significant physical examination or ECG finding at Visit 1. * 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 component. * Subjects using drugs of abuse, including abused prescription medications. * Subjects who are withdrawing from alcohol or benzodiazepines. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Subjects With Successful Bowel Cleansing | Day of colonoscopy | % of subjects with successful bowel preparation rated by colonoscopist on a 4 point scale (1=poor to 4=excellent) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Abdominal Pain (Solicited Reports) | 2 days | Percentage of patients who reported abdominal pain (with associated severity) when directly queried by study personnel, out of all patients that reported that event. |
| Abdominal Distension (Solicited Reports) | 2 days | Percentage of patients who reported abdominal distension (with associated severity) when directly queried by study personnel, out of all patients that reported that event. |
| Nausea (Solicited Reports) | 2 days | Percentage of patients who reported nausea (with associated severity) when directly queried by study personnel, out of all patients that reported that event. |
| Vomiting (Solicited Reports) | 2 days | Percentage of patients who reported vomiting (with associated severity) when directly queried by study personnel, out of all patients that reported that event. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Arm BLI4700 Bowel Preparation
BLI4700: Oral bowel preparation | 190 |
| Control Arm FDA Approved Bowel Preparation
Magnesium bowel preparation: Oral bowel preparation | 199 |
| Total | 389 |
Baseline characteristics
| Characteristic | Experimental Arm | Control Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 62 Participants | 47 Participants | 109 Participants |
| Age, Categorical Between 18 and 65 years | 128 Participants | 152 Participants | 280 Participants |
| Age, Continuous | 58.2 years STANDARD_DEVIATION 11.2 | 57.3 years STANDARD_DEVIATION 10.8 | 57.8 years STANDARD_DEVIATION 11 |
| Diabetic | 20 Participants | 14 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 16 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 171 Participants | 183 Participants | 354 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 11 Participants | 19 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 177 Participants | 183 Participants | 360 Participants |
| Region of Enrollment United States | 190 participants | 199 participants | 389 participants |
| Renal Insufficiency (GFR < 60) | 16 Participants | 14 Participants | 30 Participants |
| Sex: Female, Male Female | 112 Participants | 113 Participants | 225 Participants |
| Sex: Female, Male Male | 78 Participants | 86 Participants | 164 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 190 | 0 / 199 |
| other Total, other adverse events | 5 / 190 | 2 / 199 |
| serious Total, serious adverse events | 0 / 190 | 1 / 199 |
Outcome results
Primary
Number and Percentage of Subjects With Successful Bowel Cleansing
% of subjects with successful bowel preparation rated by colonoscopist on a 4 point scale (1=poor to 4=excellent)
Time frame: Day of colonoscopy
Population: Efficacy population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Arm | Number and Percentage of Subjects With Successful Bowel Cleansing | 175 Participants |
| Control Arm | Number and Percentage of Subjects With Successful Bowel Cleansing | 174 Participants |
p-value: <0.001Cochran-Mantel-Haenszel
Other Pre-specified
Abdominal Distension (Solicited Reports)
Percentage of patients who reported abdominal distension (with associated severity) when directly queried by study personnel, out of all patients that reported that event.
Time frame: 2 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental Arm | Abdominal Distension (Solicited Reports) | Mild | 73 percentage of patients |
| Experimental Arm | Abdominal Distension (Solicited Reports) | Moderate | 27 percentage of patients |
| Experimental Arm | Abdominal Distension (Solicited Reports) | Severe | 0 percentage of patients |
| Control Arm | Abdominal Distension (Solicited Reports) | Mild | 69 percentage of patients |
| Control Arm | Abdominal Distension (Solicited Reports) | Moderate | 31 percentage of patients |
| Control Arm | Abdominal Distension (Solicited Reports) | Severe | 0 percentage of patients |
Other Pre-specified
Abdominal Pain (Solicited Reports)
Percentage of patients who reported abdominal pain (with associated severity) when directly queried by study personnel, out of all patients that reported that event.
Time frame: 2 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental Arm | Abdominal Pain (Solicited Reports) | Mild | 82 percentage of patients |
| Experimental Arm | Abdominal Pain (Solicited Reports) | Moderate | 16 percentage of patients |
| Experimental Arm | Abdominal Pain (Solicited Reports) | Severe | 2 percentage of patients |
| Control Arm | Abdominal Pain (Solicited Reports) | Mild | 100 percentage of patients |
| Control Arm | Abdominal Pain (Solicited Reports) | Moderate | 0 percentage of patients |
| Control Arm | Abdominal Pain (Solicited Reports) | Severe | 0 percentage of patients |
Other Pre-specified
Nausea (Solicited Reports)
Percentage of patients who reported nausea (with associated severity) when directly queried by study personnel, out of all patients that reported that event.
Time frame: 2 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental Arm | Nausea (Solicited Reports) | Mild | 74 percentage of patients |
| Experimental Arm | Nausea (Solicited Reports) | Moderate | 20 percentage of patients |
| Experimental Arm | Nausea (Solicited Reports) | Severe | 6 percentage of patients |
| Control Arm | Nausea (Solicited Reports) | Mild | 94 percentage of patients |
| Control Arm | Nausea (Solicited Reports) | Moderate | 6 percentage of patients |
| Control Arm | Nausea (Solicited Reports) | Severe | 0 percentage of patients |
Other Pre-specified
Vomiting (Solicited Reports)
Percentage of patients who reported vomiting (with associated severity) when directly queried by study personnel, out of all patients that reported that event.
Time frame: 2 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental Arm | Vomiting (Solicited Reports) | Mild | 53 percentage of patients |
| Experimental Arm | Vomiting (Solicited Reports) | Moderate | 47 percentage of patients |
| Experimental Arm | Vomiting (Solicited Reports) | Severe | 0 percentage of patients |
| Control Arm | Vomiting (Solicited Reports) | Mild | 33 percentage of patients |
| Control Arm | Vomiting (Solicited Reports) | Moderate | 67 percentage of patients |
| Control Arm | Vomiting (Solicited Reports) | Severe | 0 percentage of patients |