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
DRUGPolyethylene glycol 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 * 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 or 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 |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
|---|---|
| BLI4700 Bowel Preparation BLI4700: Oral bowel preparation | 281 |
| FDA Approved Bowel Preparation Polyethylene glycol bowel preparation: Oral bowel preparation | 271 |
| Total | 552 |
Baseline characteristics
| Characteristic | BLI4700 Bowel Preparation | FDA Approved Bowel Preparation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 88 Participants | 88 Participants | 176 Participants |
| Age, Categorical Between 18 and 65 years | 193 Participants | 183 Participants | 376 Participants |
| Age, Continuous | 57.5 years STANDARD_DEVIATION 11.9 | 58.4 years STANDARD_DEVIATION 11.6 | 57.9 years STANDARD_DEVIATION 11.7 |
| Diabetic | 33 Participants | 39 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 31 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 254 Participants | 240 Participants | 494 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 10 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 43 Participants | 45 Participants | 88 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) White | 221 Participants | 212 Participants | 433 Participants |
| Renal Insufficiency (GFR < 60) | 21 Participants | 20 Participants | 41 Participants |
| Sex: Female, Male Female | 158 Participants | 152 Participants | 310 Participants |
| Sex: Female, Male Male | 123 Participants | 119 Participants | 242 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 281 | 0 / 271 |
| other Total, other adverse events | 1 / 281 | 4 / 271 |
| serious Total, serious adverse events | 0 / 281 | 2 / 271 |
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) |
|---|---|---|
| BLI4700 Bowel Preparation | Number and Percentage of Subjects With Successful Bowel Cleansing | 257 Participants |
| FDA Approved Bowel Preparation | Number and Percentage of Subjects With Successful Bowel Cleansing | 241 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) |
|---|---|---|---|
| BLI4700 Bowel Preparation | Abdominal Distension (Solicited Reports) | Mild | 68 percentage of patients |
| BLI4700 Bowel Preparation | Abdominal Distension (Solicited Reports) | Moderate | 30 percentage of patients |
| BLI4700 Bowel Preparation | Abdominal Distension (Solicited Reports) | Severe | 1 percentage of patients |
| FDA Approved Bowel Preparation | Abdominal Distension (Solicited Reports) | Mild | 71 percentage of patients |
| FDA Approved Bowel Preparation | Abdominal Distension (Solicited Reports) | Moderate | 29 percentage of patients |
| FDA Approved Bowel Preparation | 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) |
|---|---|---|---|
| BLI4700 Bowel Preparation | Abdominal Pain (Solicited Reports) | Mild | 65 percentage of patients |
| BLI4700 Bowel Preparation | Abdominal Pain (Solicited Reports) | Moderate | 35 percentage of patients |
| BLI4700 Bowel Preparation | Abdominal Pain (Solicited Reports) | Severe | 0 percentage of patients |
| FDA Approved Bowel Preparation | Abdominal Pain (Solicited Reports) | Severe | 0 percentage of patients |
| FDA Approved Bowel Preparation | Abdominal Pain (Solicited Reports) | Mild | 71 percentage of patients |
| FDA Approved Bowel Preparation | Abdominal Pain (Solicited Reports) | Moderate | 29 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) |
|---|---|---|---|
| BLI4700 Bowel Preparation | Nausea (Solicited Reports) | Mild | 71 percentage of patients |
| BLI4700 Bowel Preparation | Nausea (Solicited Reports) | Moderate | 27 percentage of patients |
| BLI4700 Bowel Preparation | Nausea (Solicited Reports) | Severe | 2 percentage of patients |
| FDA Approved Bowel Preparation | Nausea (Solicited Reports) | Mild | 77 percentage of patients |
| FDA Approved Bowel Preparation | Nausea (Solicited Reports) | Moderate | 23 percentage of patients |
| FDA Approved Bowel Preparation | 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) |
|---|---|---|---|
| BLI4700 Bowel Preparation | Vomiting (Solicited Reports) | Mild | 48 percentage of patients |
| BLI4700 Bowel Preparation | Vomiting (Solicited Reports) | Moderate | 52 percentage of patients |
| BLI4700 Bowel Preparation | Vomiting (Solicited Reports) | Severe | 0 percentage of patients |
| FDA Approved Bowel Preparation | Vomiting (Solicited Reports) | Mild | 46 percentage of patients |
| FDA Approved Bowel Preparation | Vomiting (Solicited Reports) | Moderate | 54 percentage of patients |
| FDA Approved Bowel Preparation | Vomiting (Solicited Reports) | Severe | 0 percentage of patients |