Trial Outcomes & Findings for BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy (NCT NCT00756977)
NCT ID: NCT00756977
Last Updated: 2013-08-15
Results Overview
Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent"
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
394 participants
Primary outcome timeframe
2-day
Results posted on
2013-08-15
Participant Flow
Participant milestones
| Measure |
BLI850
Single administration oral preparation
|
Polyethylene Glycol 3350 Based Bowel Preparation
Single administration oral preparation
|
|---|---|---|
|
Overall Study
STARTED
|
196
|
198
|
|
Overall Study
COMPLETED
|
175
|
187
|
|
Overall Study
NOT COMPLETED
|
21
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
Baseline characteristics by cohort
| Measure |
BLI850
n=176 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=190 Participants
|
Total
n=366 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
|
128 Participants
n=93 Participants
|
141 Participants
n=4 Participants
|
269 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
48 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
97 Participants
n=27 Participants
|
|
Age Continuous
|
56.8 years
STANDARD_DEVIATION 13.1 • n=93 Participants
|
56.9 years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
56.9 years
STANDARD_DEVIATION 12.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=93 Participants
|
104 Participants
n=4 Participants
|
201 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=93 Participants
|
86 Participants
n=4 Participants
|
165 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
176 participants
n=93 Participants
|
190 participants
n=4 Participants
|
366 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2-dayPercentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent"
Outcome measures
| Measure |
BLI850
n=176 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=188 Participants
|
|---|---|---|
|
Efficacy - Preparation Quality Using a 4 Point Scale
|
90 percentage of participants
Interval 84.0 to 94.0
|
84 percentage of participants
Interval 77.0 to 89.0
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Intent-to-treat population: all patients that took any portion of the study preparation.
Change from Baseline
Outcome measures
| Measure |
BLI850
n=176 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=190 Participants
|
|---|---|---|
|
Serum Chemistry Results (mg/dL)
Blood urea nitrogen
|
-3.08 mg/dL
Standard Deviation 3.6
|
-3.59 mg/dL
Standard Deviation 3.9
|
|
Serum Chemistry Results (mg/dL)
Calcium
|
-0.08 mg/dL
Standard Deviation 0.42
|
-0.13 mg/dL
Standard Deviation 0.43
|
|
Serum Chemistry Results (mg/dL)
Creatinine
|
0.00 mg/dL
Standard Deviation 0.14
|
0.03 mg/dL
Standard Deviation 0.12
|
|
Serum Chemistry Results (mg/dL)
Direct bilirubin
|
0.05 mg/dL
Standard Deviation 0.05
|
0.05 mg/dL
Standard Deviation 0.06
|
|
Serum Chemistry Results (mg/dL)
Glucose
|
0.82 mg/dL
Standard Deviation 32
|
-5.52 mg/dL
Standard Deviation 25
|
|
Serum Chemistry Results (mg/dL)
Phosphate
|
-0.08 mg/dL
Standard Deviation 0.65
|
-0.02 mg/dL
Standard Deviation 0.56
|
|
Serum Chemistry Results (mg/dL)
Total bilirubin
|
0.28 mg/dL
Standard Deviation 0.21
|
0.27 mg/dL
Standard Deviation 0.24
|
|
Serum Chemistry Results (mg/dL)
Uric acid
|
0.39 mg/dL
Standard Deviation 0.80
|
0.49 mg/dL
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Intent to treat population
Change from Baseline
Outcome measures
| Measure |
BLI850
n=176 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=190 Participants
|
|---|---|---|
|
Hematology Results (%)
Basophils
|
0.03 standard %
Standard Deviation 0.46
|
0.07 standard %
Standard Deviation 0.37
|
|
Hematology Results (%)
Eosinophils
|
0.06 standard %
Standard Deviation 0.95
|
-0.09 standard %
Standard Deviation 0.78
|
|
Hematology Results (%)
Hematocrit
|
0.50 standard %
Standard Deviation 3.1
|
0.38 standard %
Standard Deviation 2.6
|
|
Hematology Results (%)
Lymphocytes
|
1.09 standard %
Standard Deviation 7.3
|
0.44 standard %
Standard Deviation 6.6
|
|
Hematology Results (%)
Monocytes
|
-0.05 standard %
Standard Deviation 1.79
|
0.07 standard %
Standard Deviation 1.71
|
|
Hematology Results (%)
Neutrophils
|
-1.08 standard %
Standard Deviation 8.0
|
-0.50 standard %
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Intent-to-treat population: all patients that took any portion of the study preparation.
Change from Baseline
Outcome measures
| Measure |
BLI850
n=176 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=190 Participants
|
|---|---|---|
|
Serum Chemistry Results (U/L)
Alkaline Phosphatase
|
1.46 U/L
Standard Deviation 10.9
|
1.96 U/L
Standard Deviation 13.6
|
|
Serum Chemistry Results (U/L)
ALT
|
0.93 U/L
Standard Deviation 8.8
|
4.20 U/L
Standard Deviation 50.8
|
|
Serum Chemistry Results (U/L)
Amylase
|
-11.1 U/L
Standard Deviation 14.7
|
-16.5 U/L
Standard Deviation 97.3
|
|
Serum Chemistry Results (U/L)
AST
|
2.63 U/L
Standard Deviation 6.5
|
2.61 U/L
Standard Deviation 16.8
|
|
Serum Chemistry Results (U/L)
Creatine kinase
|
29.1 U/L
Standard Deviation 198
|
6.2 U/L
Standard Deviation 110
|
|
Serum Chemistry Results (U/L)
GGT
|
-1.38 U/L
Standard Deviation 11.8
|
0.73 U/L
Standard Deviation 19.1
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Intent-to-treat population: all patients that took any portion of the study preparation.
Change from Baseline
Outcome measures
| Measure |
BLI850
n=176 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=190 Participants
|
|---|---|---|
|
Serum Chemistry Results (mEq/L)
Anion Gap
|
0.71 mEq/L
Standard Deviation 2.70
|
0.53 mEq/L
Standard Deviation 2.79
|
|
Serum Chemistry Results (mEq/L)
Bicarbonate
|
-0.88 mEq/L
Standard Deviation 2.6
|
-0.51 mEq/L
Standard Deviation 2.5
|
|
Serum Chemistry Results (mEq/L)
Chloride
|
0.63 mEq/L
Standard Deviation 2.4
|
0.27 mEq/L
Standard Deviation 2.4
|
|
Serum Chemistry Results (mEq/L)
Magnesium
|
-0.01 mEq/L
Standard Deviation 0.13
|
-0.03 mEq/L
Standard Deviation 0.14
|
|
Serum Chemistry Results (mEq/L)
Potassium
|
-0.19 mEq/L
Standard Deviation 0.43
|
-0.24 mEq/L
Standard Deviation 0.46
|
|
Serum Chemistry Results (mEq/L)
Sodium
|
0.47 mEq/L
Standard Deviation 2.2
|
0.29 mEq/L
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Intent-to-treat population: all patients that took any portion of the study preparation.
Change from Baseline
Outcome measures
| Measure |
BLI850
n=176 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=190 Participants
|
|---|---|---|
|
Serum Chemistry Results (g/dL)
Albumin
|
0.03 g/dL
Standard Deviation 0.23
|
-0.00 g/dL
Standard Deviation 0.22
|
|
Serum Chemistry Results (g/dL)
Total protein
|
0.06 g/dL
Standard Deviation 0.38
|
0.01 g/dL
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: 2 daysChange from Baseline
Outcome measures
| Measure |
BLI850
n=176 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=190 Participants
|
|---|---|---|
|
Serum Chemistry Results (GFR)
|
-0.21 ml/min
Standard Deviation 14.6
|
-2.82 ml/min
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Intent to treat population
Change from Baseline
Outcome measures
| Measure |
BLI850
n=176 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=190 Participants
|
|---|---|---|
|
Hematology Results (1000/MCL)
Platelets
|
1.82 1000/MCL
Standard Deviation 36
|
-1.09 1000/MCL
Standard Deviation 36
|
|
Hematology Results (1000/MCL)
White blood cells
|
-0.55 1000/MCL
Standard Deviation 1.6
|
-0.59 1000/MCL
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 2 daysChange from Baseline
Outcome measures
| Measure |
BLI850
n=176 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=190 Participants
|
|---|---|---|
|
Hematology Results - Hemoglobin
|
0.20 g/dL
Standard Deviation 0.90
|
0.20 g/dL
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: 2 daysChange from Baseline
Outcome measures
| Measure |
BLI850
n=176 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=190 Participants
|
|---|---|---|
|
Hematology Results - Red Blood Cells
|
0.07 MILL/MCL
Standard Deviation 0.30
|
0.04 MILL/MCL
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: 2 daysChange from Baseline
Outcome measures
| Measure |
BLI850
n=176 Participants
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=190 Participants
|
|---|---|---|
|
Serum Chemistry Results (Osmolality)
|
-0.88 mOsm/kg
Standard Deviation 6.2
|
-0.18 mOsm/kg
Standard Deviation 7.9
|
Adverse Events
BLI850
Serious events: 0 serious events
Other events: 145 other events
Deaths: 0 deaths
Polyethylene Glycol 3350 Based Bowel Preparation
Serious events: 0 serious events
Other events: 142 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BLI850
n=176 participants at risk
|
Polyethylene Glycol 3350 Based Bowel Preparation
n=190 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
abdominal distension
|
52.3%
92/176 • 2 days
ITT Population - all subjects that took any portion of preparation
|
44.7%
85/190 • 2 days
ITT Population - all subjects that took any portion of preparation
|
|
Gastrointestinal disorders
abdominal pain
|
40.3%
71/176 • 2 days
ITT Population - all subjects that took any portion of preparation
|
41.1%
78/190 • 2 days
ITT Population - all subjects that took any portion of preparation
|
|
Gastrointestinal disorders
nausea
|
42.0%
74/176 • 2 days
ITT Population - all subjects that took any portion of preparation
|
39.5%
75/190 • 2 days
ITT Population - all subjects that took any portion of preparation
|
|
Gastrointestinal disorders
overall discomfort
|
69.3%
122/176 • 2 days
ITT Population - all subjects that took any portion of preparation
|
56.8%
108/190 • 2 days
ITT Population - all subjects that took any portion of preparation
|
|
Gastrointestinal disorders
vomiting
|
10.8%
19/176 • 2 days
ITT Population - all subjects that took any portion of preparation
|
7.9%
15/190 • 2 days
ITT Population - all subjects that took any portion of preparation
|
Additional Information
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