Colonoscopy
Conditions
Brief summary
The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel preparation prior to colonoscopy in adult patients.
Interventions
DRUGBLI4700
BLI4700 bowel preparation
Sponsors
Braintree Laboratories
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication. 2. Have previously had a colonoscopy performed 3. At least 18 years of age 4. Subjects must be scheduled for a morning colonoscopy (prior to 12:00PM) 5. If female, and of child-bearing potential, is using an acceptable form of birth control. 6. Negative urine pregnancy test at screening, if applicable 7. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study Key
Exclusion criteria
1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon. 2. Subjects who had previous significant gastrointestinal surgeries. 3. Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results. 4. Subjects with a prior history of renal, liver or cardiac insufficiency 5. Subjects with impaired consciousness that predisposes them to pulmonary aspiration. 6. Subjects undergoing colonoscopy for foreign body removal and/or decompression. 7. Subjects who are pregnant or lactating, or intending to become pregnant during the study. 8. Subjects of childbearing potential who refuse a pregnancy test. 9. Subjects allergic to any preparation components. 10. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures. 11. 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 blinded colonoscopist on a 4 point scale (1=poor, 2=fair, 3=good, 4 = excellent) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BLI4700 (Study Formulation 1) BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation | 40 |
| BLI4700 (Study Formulation 2) BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation | 37 |
| BLI4700 (Study Formulation 3) BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation | 17 |
| BLI4700 (Study Formulation 4) BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation | 20 |
| Total | 114 |
Baseline characteristics
| Characteristic | BLI4700 (Study Formulation 1) | Total | BLI4700 (Study Formulation 4) | BLI4700 (Study Formulation 3) | BLI4700 (Study Formulation 2) |
|---|---|---|---|---|---|
| Age, Continuous | 59.2 years STANDARD_DEVIATION 11.9 | 58.8 years STANDARD_DEVIATION 10.6 | 56.6 years STANDARD_DEVIATION 10.6 | 58.3 years STANDARD_DEVIATION 9.1 | 59.8 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 18 Participants | 3 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 96 Participants | 17 Participants | 17 Participants | 33 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 | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 18 Participants | 2 Participants | 3 Participants | 11 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 37 Participants | 94 Participants | 18 Participants | 14 Participants | 25 Participants |
| Region of Enrollment United States | 40 Participants | 114 Participants | 20 Participants | 17 Participants | 37 Participants |
| Sex: Female, Male Female | 19 Participants | 67 Participants | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 21 Participants | 47 Participants | 8 Participants | 5 Participants | 13 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 / 40 | 0 / 37 | 0 / 17 | 0 / 20 |
| other Total, other adverse events | 30 / 40 | 24 / 37 | 12 / 17 | 15 / 20 |
| serious Total, serious adverse events | 0 / 40 | 0 / 37 | 0 / 17 | 1 / 20 |
Outcome results
Primary
Number and Percentage of Subjects With Successful Bowel Cleansing
% of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor, 2=fair, 3=good, 4 = excellent)
Time frame: Day of colonoscopy
Population: Efficacy population - all patients that took any portion of the preparation and did not discontinue from the study for a reason other than safety or efficacy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BLI4700 (Study Formulation 1) | Number and Percentage of Subjects With Successful Bowel Cleansing | 35 Participants |
| BLI4700 (Study Formulation 2) | Number and Percentage of Subjects With Successful Bowel Cleansing | 36 Participants |
| BLI4700 (Study Formulation 3) | Number and Percentage of Subjects With Successful Bowel Cleansing | 16 Participants |
| BLI4700 (Study Formulation 4) | Number and Percentage of Subjects With Successful Bowel Cleansing | 19 Participants |