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BLI850-302: BLI850 vs an Approved Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

BLI850-302: BLI850 vs an Approved Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00756548
Enrollment
386
Registered
2008-09-22
Start date
2008-08-31
Completion date
Unknown
Last updated
2013-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

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

DRUGBLI850

multi-dose preparation for oral administration prior to colonoscopy

DRUGpolyethylene glycol 3350 based bowel preparation

multi-dose preparation for oral administration prior to colonoscopy

Sponsors

Braintree Laboratories
Lead SponsorINDUSTRY

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, intra-uterine device, 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

MeasureTime frameDescription
Efficacy - Preparation Quality Using a 4 Point Scale2 daysPercentage of patients with a successful preparation (cleaning rated as Good or Excellent)

Secondary

MeasureTime frameDescription
Hematology Results (%)2 daysChange from Baseline
Serum Chemistry Results (U/L)2 daysChange from Baseline
Serum Chemistry Results (mg/dL)2 daysChange from Baseline
Serum Chemistry Results (g/dL)2 daysChange from Baseline
Serum Chemistry Results (mEq/L)2 daysChange from Baseline
Hematology Results - Hemoglobin2 daysChange from Baseline
Hematology Results (1000/MCL)2 daysChange from Baseline
Hematology Results - Red Blood Cells2 daysChange from Baseline
Serum Chemistry Results (Osmolality)2 daysChange from Baseline
Serum Chemistry Results - Glomerular Filtration Rate2 daysChange from Baseline

Countries

United States

Participant flow

Pre-assignment details

386 subjects were randomized. 15 patients did not take the preparation are were excluded from the Intent-to-treat population.

Participants by arm

ArmCount
BLI850186
Polyethylene Glycol 3350 Based Bowel Preparation185
Total371

Baseline characteristics

CharacteristicPolyethylene Glycol 3350 Based Bowel PreparationBLI850Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
49 Participants42 Participants91 Participants
Age, Categorical
Between 18 and 65 years
136 Participants144 Participants280 Participants
Age, Continuous56.8 years
STANDARD_DEVIATION 11
56.9 years
STANDARD_DEVIATION 11.4
56.9 years
STANDARD_DEVIATION 11.2
Region of Enrollment
United States
185 participants186 participants371 participants
Sex: Female, Male
Female
108 Participants85 Participants193 Participants
Sex: Female, Male
Male
77 Participants101 Participants178 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
155 / 186147 / 185
serious
Total, serious adverse events
1 / 1860 / 185

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 days

Population: 186 patients were included in the BLI850 intent-to-treat population. One patient took the preparation but did not undergo colonoscopy due to insurance coverage issues. This patient is excluded from all efficacy analyses.

ArmMeasureValue (NUMBER)
BLI850Efficacy - Preparation Quality Using a 4 Point Scale94 percentage of participants
Polyethylene Glycol 3350 Based Bowel PreparationEfficacy - Preparation Quality Using a 4 Point Scale94 percentage of participants
Secondary

Hematology Results (%)

Change from Baseline

Time frame: 2 days

Population: Intent to treat population

ArmMeasureGroupValue (MEAN)Dispersion
BLI850Hematology Results (%)Basophils-0.00 Percentage of cellsStandard Deviation 0.48
BLI850Hematology Results (%)Eosinophils-0.06 Percentage of cellsStandard Deviation 0.98
BLI850Hematology Results (%)Hematocrit0.31 Percentage of cellsStandard Deviation 2.9
BLI850Hematology Results (%)Lymphocytes-0.83 Percentage of cellsStandard Deviation 6.4
BLI850Hematology Results (%)Monocytes0.04 Percentage of cellsStandard Deviation 1.87
BLI850Hematology Results (%)Neutrophils0.82 Percentage of cellsStandard Deviation 7.3
Polyethylene Glycol 3350 Based Bowel PreparationHematology Results (%)Monocytes0.07 Percentage of cellsStandard Deviation 1.91
Polyethylene Glycol 3350 Based Bowel PreparationHematology Results (%)Basophils-0.01 Percentage of cellsStandard Deviation 0.48
Polyethylene Glycol 3350 Based Bowel PreparationHematology Results (%)Lymphocytes0.05 Percentage of cellsStandard Deviation 6.1
Polyethylene Glycol 3350 Based Bowel PreparationHematology Results (%)Eosinophils-0.08 Percentage of cellsStandard Deviation 0.88
Polyethylene Glycol 3350 Based Bowel PreparationHematology Results (%)Neutrophils-0.03 Percentage of cellsStandard Deviation 7.1
Polyethylene Glycol 3350 Based Bowel PreparationHematology Results (%)Hematocrit0.33 Percentage of cellsStandard Deviation 2.5
Secondary

Hematology Results (1000/MCL)

Change from Baseline

Time frame: 2 days

ArmMeasureGroupValue (MEAN)Dispersion
BLI850Hematology Results (1000/MCL)White Blood Cells-0.39 1000/MCLStandard Deviation 1.65
BLI850Hematology Results (1000/MCL)Platelets0.69 1000/MCLStandard Deviation 38
Polyethylene Glycol 3350 Based Bowel PreparationHematology Results (1000/MCL)White Blood Cells-0.48 1000/MCLStandard Deviation 1.42
Polyethylene Glycol 3350 Based Bowel PreparationHematology Results (1000/MCL)Platelets-1.00 1000/MCLStandard Deviation 34
Secondary

Hematology Results - Hemoglobin

Change from Baseline

Time frame: 2 days

ArmMeasureValue (MEAN)Dispersion
BLI850Hematology Results - Hemoglobin0.22 g/dLStandard Deviation 0.72
Polyethylene Glycol 3350 Based Bowel PreparationHematology Results - Hemoglobin0.12 g/dLStandard Deviation 0.65
Secondary

Hematology Results - Red Blood Cells

Change from Baseline

Time frame: 2 days

ArmMeasureValue (MEAN)Dispersion
BLI850Hematology Results - Red Blood Cells0.07 million/microliterStandard Deviation 0.24
Polyethylene Glycol 3350 Based Bowel PreparationHematology Results - Red Blood Cells0.03 million/microliterStandard Deviation 0.22
Secondary

Serum Chemistry Results (g/dL)

Change from Baseline

Time frame: 2 days

ArmMeasureGroupValue (MEAN)Dispersion
BLI850Serum Chemistry Results (g/dL)Albumin0.07 g/dLStandard Deviation 0.22
BLI850Serum Chemistry Results (g/dL)Total protein0.13 g/dLStandard Deviation 0.34
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (g/dL)Albumin0.05 g/dLStandard Deviation 0.2
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (g/dL)Total protein0.10 g/dLStandard Deviation 0.32
Secondary

Serum Chemistry Results - Glomerular Filtration Rate

Change from Baseline

Time frame: 2 days

ArmMeasureValue (MEAN)Dispersion
BLI850Serum Chemistry Results - Glomerular Filtration Rate-0.53 ml/minStandard Deviation 12.6
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results - Glomerular Filtration Rate-0.23 ml/minStandard Deviation 11.1
Secondary

Serum Chemistry Results (mEq/L)

Change from Baseline

Time frame: 2 days

ArmMeasureGroupValue (MEAN)Dispersion
BLI850Serum Chemistry Results (mEq/L)Anion Gap (mEq/L)0.39 milliequivalent/LStandard Deviation 3.21
BLI850Serum Chemistry Results (mEq/L)Bicarbonate (mEq/L)-0.23 milliequivalent/LStandard Deviation 2.9
BLI850Serum Chemistry Results (mEq/L)Chloride (mEq/L)-0.01 milliequivalent/LStandard Deviation 2.6
BLI850Serum Chemistry Results (mEq/L)Magnesium (mEq/L)-0.01 milliequivalent/LStandard Deviation 0.12
BLI850Serum Chemistry Results (mEq/L)Potassium (mEq/L)-0.15 milliequivalent/LStandard Deviation 0.43
BLI850Serum Chemistry Results (mEq/L)Sodium (mEq/L)0.15 milliequivalent/LStandard Deviation 2.4
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (mEq/L)Potassium (mEq/L)-0.11 milliequivalent/LStandard Deviation 0.43
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (mEq/L)Anion Gap (mEq/L)0.92 milliequivalent/LStandard Deviation 2.66
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (mEq/L)Magnesium (mEq/L)-0.04 milliequivalent/LStandard Deviation 0.14
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (mEq/L)Bicarbonate (mEq/L)-1.69 milliequivalent/LStandard Deviation 2.8
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (mEq/L)Sodium (mEq/L)0.81 milliequivalent/LStandard Deviation 2.4
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (mEq/L)Chloride (mEq/L)1.58 milliequivalent/LStandard Deviation 2.3
Secondary

Serum Chemistry Results (mg/dL)

Change from Baseline

Time frame: 2 days

ArmMeasureGroupValue (MEAN)Dispersion
BLI850Serum Chemistry Results (mg/dL)Blood urea nitrogen-3.91 mg/dLStandard Deviation 3.9
BLI850Serum Chemistry Results (mg/dL)Calcium-0.14 mg/dLStandard Deviation 0.46
BLI850Serum Chemistry Results (mg/dL)Creatinine0.05 mg/dLStandard Deviation 0.14
BLI850Serum Chemistry Results (mg/dL)Direct bilirubin0.05 mg/dLStandard Deviation 0.07
BLI850Serum Chemistry Results (mg/dL)Glucose-3.78 mg/dLStandard Deviation 24
BLI850Serum Chemistry Results (mg/dL)Phosphate-0.20 mg/dLStandard Deviation 0.62
BLI850Serum Chemistry Results (mg/dL)Total bilirubin0.28 mg/dLStandard Deviation 0.34
BLI850Serum Chemistry Results (mg/dL)Uric acid0.33 mg/dLStandard Deviation 0.74
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (mg/dL)Uric acid0.00 mg/dLStandard Deviation 0.73
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (mg/dL)Blood urea nitrogen-3.01 mg/dLStandard Deviation 3.4
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (mg/dL)Glucose-4.98 mg/dLStandard Deviation 30
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (mg/dL)Calcium-0.17 mg/dLStandard Deviation 0.47
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (mg/dL)Total bilirubin0.15 mg/dLStandard Deviation 0.2
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (mg/dL)Creatinine0.00 mg/dLStandard Deviation 0.11
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (mg/dL)Phosphate-0.13 mg/dLStandard Deviation 0.62
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (mg/dL)Direct bilirubin0.04 mg/dLStandard Deviation 0.06
Secondary

Serum Chemistry Results (Osmolality)

Change from Baseline

Time frame: 2 days

ArmMeasureValue (MEAN)Dispersion
BLI850Serum Chemistry Results (Osmolality)-2.12 mOsm/kgStandard Deviation 8.6
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (Osmolality)-0.11 mOsm/kgStandard Deviation 7.9
Secondary

Serum Chemistry Results (U/L)

Change from Baseline

Time frame: 2 days

ArmMeasureGroupValue (MEAN)Dispersion
BLI850Serum Chemistry Results (U/L)Amylase-9.98 U/LStandard Deviation 11.8
BLI850Serum Chemistry Results (U/L)Alkaline phosphatase2.13 U/LStandard Deviation 10.5
BLI850Serum Chemistry Results (U/L)ALT4.34 U/LStandard Deviation 23.9
BLI850Serum Chemistry Results (U/L)AST4.11 U/LStandard Deviation 8.4
BLI850Serum Chemistry Results (U/L)Creatine kinase-5.1 U/LStandard Deviation 72
BLI850Serum Chemistry Results (U/L)GGT0.01 U/LStandard Deviation 6.6
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (U/L)Creatine kinase4.2 U/LStandard Deviation 165
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (U/L)AST4.22 U/LStandard Deviation 7.4
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (U/L)Alkaline phosphatase0.67 U/LStandard Deviation 8.3
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (U/L)GGT1.95 U/LStandard Deviation 10.4
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (U/L)ALT3.86 U/LStandard Deviation 8.6
Polyethylene Glycol 3350 Based Bowel PreparationSerum Chemistry Results (U/L)Amylase-6.55 U/LStandard Deviation 13.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026