Trial Outcomes & Findings for BLI850-302: BLI850 vs an Approved Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy (NCT NCT00756548)
NCT ID: NCT00756548
Last Updated: 2013-12-27
Results Overview
Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent")
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
386 participants
Primary outcome timeframe
2 days
Results posted on
2013-12-27
Participant Flow
386 subjects were randomized. 15 patients did not take the preparation are were excluded from the Intent-to-treat population.
Participant milestones
| Measure |
BLI850
single administration oral preparation - split dose
|
Polyethylene Glycol 3350 Based Bowel Preparation
single administration oral preparation - split dose
|
|---|---|---|
|
Overall Study
STARTED
|
186
|
185
|
|
Overall Study
COMPLETED
|
184
|
185
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BLI850-302: BLI850 vs an Approved Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
Baseline characteristics by cohort
| Measure |
BLI850
n=186 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=185 Participants
|
Total
n=371 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
144 Participants
n=93 Participants
|
136 Participants
n=4 Participants
|
280 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
42 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
91 Participants
n=27 Participants
|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 11.4 • n=93 Participants
|
56.8 years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
56.9 years
STANDARD_DEVIATION 11.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=93 Participants
|
108 Participants
n=4 Participants
|
193 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=93 Participants
|
77 Participants
n=4 Participants
|
178 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
186 participants
n=93 Participants
|
185 participants
n=4 Participants
|
371 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 daysPopulation: 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.
Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent")
Outcome measures
| Measure |
BLI850
n=185 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=185 Participants
|
|---|---|---|
|
Efficacy - Preparation Quality Using a 4 Point Scale
|
94 percentage of participants
Interval 89.0 to 97.0
|
94 percentage of participants
Interval 89.0 to 97.0
|
SECONDARY outcome
Timeframe: 2 daysChange from Baseline
Outcome measures
| Measure |
BLI850
n=186 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=185 Participants
|
|---|---|---|
|
Serum Chemistry Results (mEq/L)
Anion Gap (mEq/L)
|
0.39 milliequivalent/L
Standard Deviation 3.21
|
0.92 milliequivalent/L
Standard Deviation 2.66
|
|
Serum Chemistry Results (mEq/L)
Bicarbonate (mEq/L)
|
-0.23 milliequivalent/L
Standard Deviation 2.9
|
-1.69 milliequivalent/L
Standard Deviation 2.8
|
|
Serum Chemistry Results (mEq/L)
Chloride (mEq/L)
|
-0.01 milliequivalent/L
Standard Deviation 2.6
|
1.58 milliequivalent/L
Standard Deviation 2.3
|
|
Serum Chemistry Results (mEq/L)
Magnesium (mEq/L)
|
-0.01 milliequivalent/L
Standard Deviation 0.12
|
-0.04 milliequivalent/L
Standard Deviation 0.14
|
|
Serum Chemistry Results (mEq/L)
Potassium (mEq/L)
|
-0.15 milliequivalent/L
Standard Deviation 0.43
|
-0.11 milliequivalent/L
Standard Deviation 0.43
|
|
Serum Chemistry Results (mEq/L)
Sodium (mEq/L)
|
0.15 milliequivalent/L
Standard Deviation 2.4
|
0.81 milliequivalent/L
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Intent to treat population
Change from Baseline
Outcome measures
| Measure |
BLI850
n=186 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=185 Participants
|
|---|---|---|
|
Hematology Results (%)
Basophils
|
-0.00 Percentage of cells
Standard Deviation 0.48
|
-0.01 Percentage of cells
Standard Deviation 0.48
|
|
Hematology Results (%)
Eosinophils
|
-0.06 Percentage of cells
Standard Deviation 0.98
|
-0.08 Percentage of cells
Standard Deviation 0.88
|
|
Hematology Results (%)
Hematocrit
|
0.31 Percentage of cells
Standard Deviation 2.9
|
0.33 Percentage of cells
Standard Deviation 2.5
|
|
Hematology Results (%)
Lymphocytes
|
-0.83 Percentage of cells
Standard Deviation 6.4
|
0.05 Percentage of cells
Standard Deviation 6.1
|
|
Hematology Results (%)
Monocytes
|
0.04 Percentage of cells
Standard Deviation 1.87
|
0.07 Percentage of cells
Standard Deviation 1.91
|
|
Hematology Results (%)
Neutrophils
|
0.82 Percentage of cells
Standard Deviation 7.3
|
-0.03 Percentage of cells
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: 2 daysChange from Baseline
Outcome measures
| Measure |
BLI850
n=186 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=185 Participants
|
|---|---|---|
|
Serum Chemistry Results (U/L)
Alkaline phosphatase
|
2.13 U/L
Standard Deviation 10.5
|
0.67 U/L
Standard Deviation 8.3
|
|
Serum Chemistry Results (U/L)
ALT
|
4.34 U/L
Standard Deviation 23.9
|
3.86 U/L
Standard Deviation 8.6
|
|
Serum Chemistry Results (U/L)
Amylase
|
-9.98 U/L
Standard Deviation 11.8
|
-6.55 U/L
Standard Deviation 13.7
|
|
Serum Chemistry Results (U/L)
AST
|
4.11 U/L
Standard Deviation 8.4
|
4.22 U/L
Standard Deviation 7.4
|
|
Serum Chemistry Results (U/L)
Creatine kinase
|
-5.1 U/L
Standard Deviation 72
|
4.2 U/L
Standard Deviation 165
|
|
Serum Chemistry Results (U/L)
GGT
|
0.01 U/L
Standard Deviation 6.6
|
1.95 U/L
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: 2 daysChange from Baseline
Outcome measures
| Measure |
BLI850
n=186 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=185 Participants
|
|---|---|---|
|
Serum Chemistry Results (mg/dL)
Uric acid
|
0.33 mg/dL
Standard Deviation 0.74
|
0.00 mg/dL
Standard Deviation 0.73
|
|
Serum Chemistry Results (mg/dL)
Blood urea nitrogen
|
-3.91 mg/dL
Standard Deviation 3.9
|
-3.01 mg/dL
Standard Deviation 3.4
|
|
Serum Chemistry Results (mg/dL)
Calcium
|
-0.14 mg/dL
Standard Deviation 0.46
|
-0.17 mg/dL
Standard Deviation 0.47
|
|
Serum Chemistry Results (mg/dL)
Creatinine
|
0.05 mg/dL
Standard Deviation 0.14
|
0.00 mg/dL
Standard Deviation 0.11
|
|
Serum Chemistry Results (mg/dL)
Direct bilirubin
|
0.05 mg/dL
Standard Deviation 0.07
|
0.04 mg/dL
Standard Deviation 0.06
|
|
Serum Chemistry Results (mg/dL)
Glucose
|
-3.78 mg/dL
Standard Deviation 24
|
-4.98 mg/dL
Standard Deviation 30
|
|
Serum Chemistry Results (mg/dL)
Phosphate
|
-0.20 mg/dL
Standard Deviation 0.62
|
-0.13 mg/dL
Standard Deviation 0.62
|
|
Serum Chemistry Results (mg/dL)
Total bilirubin
|
0.28 mg/dL
Standard Deviation 0.34
|
0.15 mg/dL
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: 2 daysChange from Baseline
Outcome measures
| Measure |
BLI850
n=186 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=185 Participants
|
|---|---|---|
|
Serum Chemistry Results (g/dL)
Albumin
|
0.07 g/dL
Standard Deviation 0.22
|
0.05 g/dL
Standard Deviation 0.20
|
|
Serum Chemistry Results (g/dL)
Total protein
|
0.13 g/dL
Standard Deviation 0.34
|
0.10 g/dL
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: 2 daysChange from Baseline
Outcome measures
| Measure |
BLI850
n=186 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=185 Participants
|
|---|---|---|
|
Serum Chemistry Results - Glomerular Filtration Rate
|
-0.53 ml/min
Standard Deviation 12.6
|
-0.23 ml/min
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: 2 daysChange from Baseline
Outcome measures
| Measure |
BLI850
n=186 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=185 Participants
|
|---|---|---|
|
Hematology Results - Hemoglobin
|
0.22 g/dL
Standard Deviation 0.72
|
0.12 g/dL
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: 2 daysChange from Baseline
Outcome measures
| Measure |
BLI850
n=186 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=185 Participants
|
|---|---|---|
|
Hematology Results (1000/MCL)
Platelets
|
0.69 1000/MCL
Standard Deviation 38
|
-1.00 1000/MCL
Standard Deviation 34
|
|
Hematology Results (1000/MCL)
White Blood Cells
|
-0.39 1000/MCL
Standard Deviation 1.65
|
-0.48 1000/MCL
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: 2 daysChange from Baseline
Outcome measures
| Measure |
BLI850
n=186 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=185 Participants
|
|---|---|---|
|
Hematology Results - Red Blood Cells
|
0.07 million/microliter
Standard Deviation 0.24
|
0.03 million/microliter
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: 2 daysChange from Baseline
Outcome measures
| Measure |
BLI850
n=186 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=185 Participants
|
|---|---|---|
|
Serum Chemistry Results (Osmolality)
|
-2.12 mOsm/kg
Standard Deviation 8.6
|
-0.11 mOsm/kg
Standard Deviation 7.9
|
Adverse Events
BLI850
Serious events: 1 serious events
Other events: 155 other events
Deaths: 0 deaths
Polyethylene Glycol 3350 Based Bowel Preparation
Serious events: 0 serious events
Other events: 147 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BLI850
n=186 participants at risk
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=185 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
abdominal cramping
|
0.54%
1/186
|
0.00%
0/185
|
Other adverse events
| Measure |
BLI850
n=186 participants at risk
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=185 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
51.6%
96/186
|
60.5%
112/185
|
|
Gastrointestinal disorders
Abdominal pain
|
37.6%
70/186
|
42.7%
79/185
|
|
Gastrointestinal disorders
Nausea
|
46.2%
86/186
|
38.9%
72/185
|
|
Gastrointestinal disorders
Overall discomfort
|
62.4%
116/186
|
65.4%
121/185
|
|
Gastrointestinal disorders
Vomiting
|
14.0%
26/186
|
7.0%
13/185
|
Additional Information
John McGowan, Director, Clinical Research
Braintree Laboratories, Inc.
Phone: 781-843-2202
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 360 days from the time submitted to the sponsor for review. The sponsor cannot extent the embargo.
- Publication restrictions are in place
Restriction type: OTHER