Colon Cancer
Conditions
Keywords
Colonoscopy, screening
Brief summary
This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.
Interventions
multi-dose preparation for oral administration prior to colonoscopy
DRUGBLI850
multi-dose preparation 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
1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication, including: * Evaluation of barium enema results * GI bleeding * Anemia of unknown etiology * Neoplastic disease surveillance * Abnormal Endosonography * Inflammatory bowel disease * Unknown diarrhea or constipation etiology * Polypectomy * Laser therapy * Routine screening 2. At least 18 years of age. 3. Otherwise in good health, as determined by physical exam and medical history. 4. 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). 5. Negative urine pregnancy test at screening, if applicable. 6. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study.
Exclusion criteria
1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon. 2. Subjects with impaired consciousness that predisposes them to pulmonary aspiration. 3. Subjects who are undergoing colonoscopy for foreign body removal or decompression. 4. Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results. 5. Subjects who had previous significant gastrointestinal surgeries (e.g. colostomy, colectomy, gastric bypass). 6. Subjects who are pregnant or lactating, or intending to become pregnant during the study. 7. Subjects of childbearing potential who refuse a pregnancy test. 8. Subjects who are allergic to any preparation components 9. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures. 10. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - Preparation Quality Using a 4 Point Scale | 2-day | Percentage of patients with a successful preparation (cleaning rated as Good or Excellent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hematology Results (%) | 2 days | Change from Baseline |
| Serum Chemistry Results (U/L) | 2 days | Change from Baseline |
| Serum Chemistry Results (mEq/L) | 2 days | Change from Baseline |
| Serum Chemistry Results (g/dL) | 2 days | Change from Baseline |
| Serum Chemistry Results (mg/dL) | 2 days | Change from Baseline |
| Hematology Results (1000/MCL) | 2 days | Change from Baseline |
| Hematology Results - Hemoglobin | 2 days | Change from Baseline |
| Hematology Results - Red Blood Cells | 2 days | Change from Baseline |
| Serum Chemistry Results (Osmolality) | 2 days | Change from Baseline |
| Serum Chemistry Results (GFR) | 2 days | Change from Baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BLI850 | 176 |
| Polyethylene Glycol 3350 Based Bowel Preparation | 190 |
| Total | 366 |
Baseline characteristics
| Characteristic | Polyethylene Glycol 3350 Based Bowel Preparation | BLI850 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 49 Participants | 48 Participants | 97 Participants |
| Age, Categorical Between 18 and 65 years | 141 Participants | 128 Participants | 269 Participants |
| Age Continuous | 56.9 years STANDARD_DEVIATION 12.3 | 56.8 years STANDARD_DEVIATION 13.1 | 56.9 years STANDARD_DEVIATION 12.7 |
| Region of Enrollment United States | 190 participants | 176 participants | 366 participants |
| Sex: Female, Male Female | 104 Participants | 97 Participants | 201 Participants |
| Sex: Female, Male Male | 86 Participants | 79 Participants | 165 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 145 / 176 | 142 / 190 |
| serious Total, serious adverse events | 0 / 176 | 0 / 190 |
Outcome results
Primary
Efficacy - Preparation Quality Using a 4 Point Scale
Percentage of patients with a successful preparation (cleaning rated as Good or Excellent
Time frame: 2-day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BLI850 | Efficacy - Preparation Quality Using a 4 Point Scale | 90 percentage of participants |
| Polyethylene Glycol 3350 Based Bowel Preparation | Efficacy - Preparation Quality Using a 4 Point Scale | 84 percentage of participants |
Secondary
Hematology Results (%)
Change from Baseline
Time frame: 2 days
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BLI850 | Hematology Results (%) | Basophils | 0.03 standard % | Standard Deviation 0.46 |
| BLI850 | Hematology Results (%) | Eosinophils | 0.06 standard % | Standard Deviation 0.95 |
| BLI850 | Hematology Results (%) | Hematocrit | 0.50 standard % | Standard Deviation 3.1 |
| BLI850 | Hematology Results (%) | Lymphocytes | 1.09 standard % | Standard Deviation 7.3 |
| BLI850 | Hematology Results (%) | Monocytes | -0.05 standard % | Standard Deviation 1.79 |
| BLI850 | Hematology Results (%) | Neutrophils | -1.08 standard % | Standard Deviation 8 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Hematology Results (%) | Monocytes | 0.07 standard % | Standard Deviation 1.71 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Hematology Results (%) | Basophils | 0.07 standard % | Standard Deviation 0.37 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Hematology Results (%) | Lymphocytes | 0.44 standard % | Standard Deviation 6.6 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Hematology Results (%) | Eosinophils | -0.09 standard % | Standard Deviation 0.78 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Hematology Results (%) | Neutrophils | -0.50 standard % | Standard Deviation 7.7 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Hematology Results (%) | Hematocrit | 0.38 standard % | Standard Deviation 2.6 |
Secondary
Hematology Results (1000/MCL)
Change from Baseline
Time frame: 2 days
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BLI850 | Hematology Results (1000/MCL) | Platelets | 1.82 1000/MCL | Standard Deviation 36 |
| BLI850 | Hematology Results (1000/MCL) | White blood cells | -0.55 1000/MCL | Standard Deviation 1.6 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Hematology Results (1000/MCL) | Platelets | -1.09 1000/MCL | Standard Deviation 36 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Hematology Results (1000/MCL) | White blood cells | -0.59 1000/MCL | Standard Deviation 1.6 |
Secondary
Hematology Results - Hemoglobin
Change from Baseline
Time frame: 2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BLI850 | Hematology Results - Hemoglobin | 0.20 g/dL | Standard Deviation 0.9 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Hematology Results - Hemoglobin | 0.20 g/dL | Standard Deviation 0.75 |
Secondary
Hematology Results - Red Blood Cells
Change from Baseline
Time frame: 2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BLI850 | Hematology Results - Red Blood Cells | 0.07 MILL/MCL | Standard Deviation 0.3 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Hematology Results - Red Blood Cells | 0.04 MILL/MCL | Standard Deviation 0.26 |
Secondary
Serum Chemistry Results (g/dL)
Change from Baseline
Time frame: 2 days
Population: Intent-to-treat population: all patients that took any portion of the study preparation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BLI850 | Serum Chemistry Results (g/dL) | Albumin | 0.03 g/dL | Standard Deviation 0.23 |
| BLI850 | Serum Chemistry Results (g/dL) | Total protein | 0.06 g/dL | Standard Deviation 0.38 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (g/dL) | Albumin | -0.00 g/dL | Standard Deviation 0.22 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (g/dL) | Total protein | 0.01 g/dL | Standard Deviation 0.36 |
Secondary
Serum Chemistry Results (GFR)
Change from Baseline
Time frame: 2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BLI850 | Serum Chemistry Results (GFR) | -0.21 ml/min | Standard Deviation 14.6 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (GFR) | -2.82 ml/min | Standard Deviation 11.5 |
Secondary
Serum Chemistry Results (mEq/L)
Change from Baseline
Time frame: 2 days
Population: Intent-to-treat population: all patients that took any portion of the study preparation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BLI850 | Serum Chemistry Results (mEq/L) | Anion Gap | 0.71 mEq/L | Standard Deviation 2.7 |
| BLI850 | Serum Chemistry Results (mEq/L) | Bicarbonate | -0.88 mEq/L | Standard Deviation 2.6 |
| BLI850 | Serum Chemistry Results (mEq/L) | Chloride | 0.63 mEq/L | Standard Deviation 2.4 |
| BLI850 | Serum Chemistry Results (mEq/L) | Magnesium | -0.01 mEq/L | Standard Deviation 0.13 |
| BLI850 | Serum Chemistry Results (mEq/L) | Potassium | -0.19 mEq/L | Standard Deviation 0.43 |
| BLI850 | Serum Chemistry Results (mEq/L) | Sodium | 0.47 mEq/L | Standard Deviation 2.2 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (mEq/L) | Potassium | -0.24 mEq/L | Standard Deviation 0.46 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (mEq/L) | Anion Gap | 0.53 mEq/L | Standard Deviation 2.79 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (mEq/L) | Magnesium | -0.03 mEq/L | Standard Deviation 0.14 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (mEq/L) | Bicarbonate | -0.51 mEq/L | Standard Deviation 2.5 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (mEq/L) | Sodium | 0.29 mEq/L | Standard Deviation 2.2 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (mEq/L) | Chloride | 0.27 mEq/L | Standard Deviation 2.4 |
Secondary
Serum Chemistry Results (mg/dL)
Change from Baseline
Time frame: 2 days
Population: Intent-to-treat population: all patients that took any portion of the study preparation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BLI850 | Serum Chemistry Results (mg/dL) | Blood urea nitrogen | -3.08 mg/dL | Standard Deviation 3.6 |
| BLI850 | Serum Chemistry Results (mg/dL) | Calcium | -0.08 mg/dL | Standard Deviation 0.42 |
| BLI850 | Serum Chemistry Results (mg/dL) | Creatinine | 0.00 mg/dL | Standard Deviation 0.14 |
| BLI850 | Serum Chemistry Results (mg/dL) | Direct bilirubin | 0.05 mg/dL | Standard Deviation 0.05 |
| BLI850 | Serum Chemistry Results (mg/dL) | Glucose | 0.82 mg/dL | Standard Deviation 32 |
| BLI850 | Serum Chemistry Results (mg/dL) | Phosphate | -0.08 mg/dL | Standard Deviation 0.65 |
| BLI850 | Serum Chemistry Results (mg/dL) | Total bilirubin | 0.28 mg/dL | Standard Deviation 0.21 |
| BLI850 | Serum Chemistry Results (mg/dL) | Uric acid | 0.39 mg/dL | Standard Deviation 0.8 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (mg/dL) | Uric acid | 0.49 mg/dL | Standard Deviation 0.77 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (mg/dL) | Blood urea nitrogen | -3.59 mg/dL | Standard Deviation 3.9 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (mg/dL) | Glucose | -5.52 mg/dL | Standard Deviation 25 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (mg/dL) | Calcium | -0.13 mg/dL | Standard Deviation 0.43 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (mg/dL) | Total bilirubin | 0.27 mg/dL | Standard Deviation 0.24 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (mg/dL) | Creatinine | 0.03 mg/dL | Standard Deviation 0.12 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (mg/dL) | Phosphate | -0.02 mg/dL | Standard Deviation 0.56 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (mg/dL) | Direct bilirubin | 0.05 mg/dL | Standard Deviation 0.06 |
Secondary
Serum Chemistry Results (Osmolality)
Change from Baseline
Time frame: 2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BLI850 | Serum Chemistry Results (Osmolality) | -0.88 mOsm/kg | Standard Deviation 6.2 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (Osmolality) | -0.18 mOsm/kg | Standard Deviation 7.9 |
Secondary
Serum Chemistry Results (U/L)
Change from Baseline
Time frame: 2 days
Population: Intent-to-treat population: all patients that took any portion of the study preparation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BLI850 | Serum Chemistry Results (U/L) | Alkaline Phosphatase | 1.46 U/L | Standard Deviation 10.9 |
| BLI850 | Serum Chemistry Results (U/L) | ALT | 0.93 U/L | Standard Deviation 8.8 |
| BLI850 | Serum Chemistry Results (U/L) | Amylase | -11.1 U/L | Standard Deviation 14.7 |
| BLI850 | Serum Chemistry Results (U/L) | AST | 2.63 U/L | Standard Deviation 6.5 |
| BLI850 | Serum Chemistry Results (U/L) | Creatine kinase | 29.1 U/L | Standard Deviation 198 |
| BLI850 | Serum Chemistry Results (U/L) | GGT | -1.38 U/L | Standard Deviation 11.8 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (U/L) | Creatine kinase | 6.2 U/L | Standard Deviation 110 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (U/L) | Alkaline Phosphatase | 1.96 U/L | Standard Deviation 13.6 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (U/L) | AST | 2.61 U/L | Standard Deviation 16.8 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (U/L) | ALT | 4.20 U/L | Standard Deviation 50.8 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (U/L) | GGT | 0.73 U/L | Standard Deviation 19.1 |
| Polyethylene Glycol 3350 Based Bowel Preparation | Serum Chemistry Results (U/L) | Amylase | -16.5 U/L | Standard Deviation 97.3 |