Colonoscopy
Conditions
Brief summary
The purpose of this study is to compare the safety and efficacy of BLI4900 bowel preparation to an FDA-approved control as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.
Interventions
DRUGBowel Prep
Orally ingested liquid 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 inflammatory bowel disease who have a history of any bowel resection (small intestine or colon), suspected active inflammation, or symptoms suggestive of obstruction or known bowel stricture. * Subjects who had previous significant gastrointestinal surgeries. * Subjects who have regularly used laxatives or colon motility altering drugs in the last month (i.e. more than 2-3 times per week) and/or laxative use within 72 hours prior to administration of the preparation * 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. * Subjects with uncontrolled hypertension. * Subjects taking antibiotics within 7 days of colonoscopy. * Subjects with severe renal, hepatic or cardiac insufficiency. * 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 taking tricyclic antidepressants. * Subjects using drugs of abuse, including abused prescription medications. * Subjects who are withdrawing from alcohol or benzodiazepines.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With Successful Bowel Preparation | 2 days | Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BLI4900 Experimental bowel preparation solution for oral ingestion
Bowel Prep: Orally ingested liquid bowel preparation | 250 |
| FDA Approved Control FDA approved bowel preparation solution for oral ingestion
Bowel Prep: Orally ingested liquid bowel preparation | 250 |
| Total | 500 |
Baseline characteristics
| Characteristic | BLI4900 | FDA Approved Control | Total |
|---|---|---|---|
| Age, Continuous | 56.4 years STANDARD_DEVIATION 11.8 | 56.1 years STANDARD_DEVIATION 11.7 | 56.2 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 55 Participants | 48 Participants | 103 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 195 Participants | 202 Participants | 397 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 4 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 29 Participants | 55 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 | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) White | 209 Participants | 213 Participants | 422 Participants |
| Region of Enrollment United States | 250 Participants | 250 Participants | 500 Participants |
| Sex: Female, Male Female | 142 Participants | 152 Participants | 294 Participants |
| Sex: Female, Male Male | 108 Participants | 98 Participants | 206 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 227 | 0 / 226 |
| other Total, other adverse events | 23 / 227 | 26 / 226 |
| serious Total, serious adverse events | 0 / 227 | 2 / 226 |
Outcome results
Primary
Proportion of Subjects With Successful Bowel Preparation
Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor).
Time frame: 2 days
Population: Modified intent-to-treat population - this population includes all subjects that took any portion of study preparation and who did not withdraw for a reason other than safety, efficacy or tolerance.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BLI4900 | Proportion of Subjects With Successful Bowel Preparation | 212 Participants |
| FDA Approved Control | Proportion of Subjects With Successful Bowel Preparation | 211 Participants |
p-value: <0.00195% CI: [-3.97, 4.27]Mantel Haenszel