Bowel Preparation, Colonoscopy, Endoscopy
Conditions
Keywords
colonoscopy, bowel preparation, endoscopy
Brief summary
The objective of this study is to compare the safety, tolerance and efficacy of BLI800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonoscopy in adult patients, particularly including the elderly and those with renal and/or hepatic impairment.
Interventions
DRUGPEG-3350 based bowel preparation
solution for oral administration prior to colonoscopy
DRUGBLI800 approved preparation regimen
solution for oral administration prior to colonoscopy
DRUGBLI800 investigational preparation regimen
solution for oral administration prior to colonoscopy
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication. * At least 18 years of age * If female, and of child-bearing potential, is using an acceptable form of birth control * 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 who had previous significant gastrointestinal surgeries. * Subjects who have uncontrolled clinically significant pre-existing electrolyte disturbances. * Subjects with severe liver or renal insufficiency. * Subjects with a history of congestive heart failure or other clinically significant cardiac abnormality. * Subjects with impaired consciousness that predisposes them to pulmonary aspiration. * Subjects undergoing colonoscopy for foreign body removal and 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Successful Bowel Preparation | Day of colonoscopy | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | 2 days | Count and Percentage of subjects with AEs through Day of Colonoscopy based on 3% threshold. Outcome measure time frame represents the day prior to colonoscopy (when preparation Dose 1 is taken) and the day of colonoscopy (when preparation Dose 2 is taken). |
| Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7 | 7 days | Count and Percentage of subjects with AEs reported after colonoscopy through follow-up Day 7 based on 3% threshold. Outcome measure time frame represents the period following colonoscopy through follow-up Day 7 (7 days). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BLI800 Approved Preparation Regimen BLI800 approved preparation regimen
BLI800 approved preparation regimen: solution for oral administration prior to colonoscopy | 184 |
| BLI800 Investigational Preparation Regimen BLI800 investigational preparation regimen
BLI800 investigational preparation regimen: solution for oral administration prior to colonoscopy | 180 |
| PEG-3350 Based Bowel Preparation PEG-3350 based bowel preparation
PEG-3350 based bowel preparation: solution for oral administration prior to colonoscopy | 177 |
| Total | 541 |
Baseline characteristics
| Characteristic | BLI800 Approved Preparation Regimen | Total | PEG-3350 Based Bowel Preparation | BLI800 Investigational Preparation Regimen |
|---|---|---|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 11.5 | 57.0 years STANDARD_DEVIATION 10.9 | 56.6 years STANDARD_DEVIATION 10.9 | 57.6 years STANDARD_DEVIATION 10.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 52 Participants | 18 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 169 Participants | 489 Participants | 159 Participants | 161 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 14 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 75 Participants | 31 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 156 Participants | 451 Participants | 139 Participants | 156 Participants |
| Region of Enrollment United States | 184 Participants | 541 Participants | 177 Participants | 180 Participants |
| Sex: Female, Male Female | 101 Participants | 319 Participants | 111 Participants | 107 Participants |
| Sex: Female, Male Male | 83 Participants | 222 Participants | 66 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 184 | 1 / 180 | 0 / 177 |
| other Total, other adverse events | 145 / 184 | 129 / 180 | 127 / 177 |
| serious Total, serious adverse events | 4 / 184 | 12 / 180 | 3 / 177 |
Outcome results
Primary
Percentage 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: Day of colonoscopy
Population: The Primary Efficacy Outcome includes all patients that took a portion of study preparation, except those that did not undergo colonoscopy for a reason other than safety or efficacy (e.g., patient could not get a ride to their colonoscopy).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BLI800 Approved Preparation Regimen | Percentage of Subjects With Successful Bowel Preparation | 175 Participants |
| BLI800 Investigational Preparation Regimen | Percentage of Subjects With Successful Bowel Preparation | 132 Participants |
| PEG-3350 Based Bowel Preparation | Percentage of Subjects With Successful Bowel Preparation | 137 Participants |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7
Count and Percentage of subjects with AEs reported after colonoscopy through follow-up Day 7 based on 3% threshold. Outcome measure time frame represents the period following colonoscopy through follow-up Day 7 (7 days).
Time frame: 7 days
Population: All subjects who took a portion of study preparation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BLI800 Approved Preparation Regimen | Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7 | Abdominal distension | 10 Participants |
| BLI800 Approved Preparation Regimen | Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7 | Nausea | 3 Participants |
| BLI800 Approved Preparation Regimen | Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7 | Abdominal pain | 11 Participants |
| BLI800 Investigational Preparation Regimen | Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7 | Abdominal distension | 18 Participants |
| BLI800 Investigational Preparation Regimen | Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7 | Nausea | 11 Participants |
| BLI800 Investigational Preparation Regimen | Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7 | Abdominal pain | 10 Participants |
| PEG-3350 Based Bowel Preparation | Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7 | Nausea | 7 Participants |
| PEG-3350 Based Bowel Preparation | Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7 | Abdominal pain | 11 Participants |
| PEG-3350 Based Bowel Preparation | Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7 | Abdominal distension | 25 Participants |
Secondary
Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy
Count and Percentage of subjects with AEs through Day of Colonoscopy based on 3% threshold. Outcome measure time frame represents the day prior to colonoscopy (when preparation Dose 1 is taken) and the day of colonoscopy (when preparation Dose 2 is taken).
Time frame: 2 days
Population: All subjects that took any portion of study preparation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BLI800 Approved Preparation Regimen | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Abdominal pain | 65 Participants |
| BLI800 Approved Preparation Regimen | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Discomfort | 105 Participants |
| BLI800 Approved Preparation Regimen | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Vomiting | 14 Participants |
| BLI800 Approved Preparation Regimen | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Abdominal distension | 79 Participants |
| BLI800 Approved Preparation Regimen | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Headache | 6 Participants |
| BLI800 Approved Preparation Regimen | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Anion gap increased | 9 Participants |
| BLI800 Approved Preparation Regimen | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Nausea | 77 Participants |
| BLI800 Investigational Preparation Regimen | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Vomiting | 18 Participants |
| BLI800 Investigational Preparation Regimen | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Abdominal distension | 75 Participants |
| BLI800 Investigational Preparation Regimen | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Abdominal pain | 56 Participants |
| BLI800 Investigational Preparation Regimen | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Nausea | 50 Participants |
| BLI800 Investigational Preparation Regimen | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Discomfort | 92 Participants |
| BLI800 Investigational Preparation Regimen | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Anion gap increased | 6 Participants |
| BLI800 Investigational Preparation Regimen | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Headache | 7 Participants |
| PEG-3350 Based Bowel Preparation | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Discomfort | 90 Participants |
| PEG-3350 Based Bowel Preparation | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Abdominal pain | 50 Participants |
| PEG-3350 Based Bowel Preparation | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Headache | 11 Participants |
| PEG-3350 Based Bowel Preparation | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Anion gap increased | 4 Participants |
| PEG-3350 Based Bowel Preparation | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Vomiting | 13 Participants |
| PEG-3350 Based Bowel Preparation | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Nausea | 54 Participants |
| PEG-3350 Based Bowel Preparation | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Abdominal distension | 83 Participants |