Trial Outcomes & Findings for BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects (NCT NCT00856843)
NCT ID: NCT00856843
Last Updated: 2010-11-10
Results Overview
Blinded colonoscopists rated cleansing quality as either Excellent, Good, Fair or Poor. Scores of Excellent or Good were considered Successful preparations.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
136 participants
Primary outcome timeframe
2 days
Results posted on
2010-11-10
Participant Flow
Participant milestones
| Measure |
Polyethylene Glycol 3350 Based Bowel Preparation
Active control - oral solution, 1 administration
|
BLI800
Investigational prep - oral solution, 1 administration
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
68
|
|
Overall Study
COMPLETED
|
66
|
63
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Polyethylene Glycol 3350 Based Bowel Preparation
Active control - oral solution, 1 administration
|
BLI800
Investigational prep - oral solution, 1 administration
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
Baseline Characteristics
BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Baseline characteristics by cohort
| Measure |
Polyethylene Glycol 3350 Based Bowel Preparation
n=68 Participants
Active control - oral solution, 1 administration
|
BLI800
n=68 Participants
Investigational prep - oral solution, 1 administration
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age Continuous
|
56.7 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
57.2 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
68 participants
n=7 Participants
|
136 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 daysBlinded colonoscopists rated cleansing quality as either Excellent, Good, Fair or Poor. Scores of Excellent or Good were considered Successful preparations.
Outcome measures
| Measure |
Polyethylene Glycol 3350 Based Bowel Preparation
n=67 Participants
Active control - oral solution, 1 administration
|
BLI800
n=63 Participants
Investigational prep - oral solution, 1 administration
|
|---|---|---|
|
Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale
|
89.6 percentage of participants
|
98.4 percentage of participants
|
SECONDARY outcome
Timeframe: 2 daysThe blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Outcome measures
| Measure |
Polyethylene Glycol 3350 Based Bowel Preparation
n=67 Participants
Active control - oral solution, 1 administration
|
BLI800
n=63 Participants
Investigational prep - oral solution, 1 administration
|
|---|---|---|
|
Assessment of Residual Stool - Cecum
Absent
|
67 percentage of participants
|
91 percentage of participants
|
|
Assessment of Residual Stool - Cecum
Small
|
22 percentage of participants
|
9 percentage of participants
|
|
Assessment of Residual Stool - Cecum
Moderate
|
5 percentage of participants
|
0 percentage of participants
|
|
Assessment of Residual Stool - Cecum
Excess
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 daysThe blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Outcome measures
| Measure |
Polyethylene Glycol 3350 Based Bowel Preparation
n=67 Participants
Active control - oral solution, 1 administration
|
BLI800
n=63 Participants
Investigational prep - oral solution, 1 administration
|
|---|---|---|
|
Assessment of Residual Stool - Ascending Colon
Absent
|
69 percentage of participants
|
91 percentage of participants
|
|
Assessment of Residual Stool - Ascending Colon
Small
|
24 percentage of participants
|
9 percentage of participants
|
|
Assessment of Residual Stool - Ascending Colon
Moderate
|
2 percentage of participants
|
0 percentage of participants
|
|
Assessment of Residual Stool - Ascending Colon
Excess
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 daysThe blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Outcome measures
| Measure |
Polyethylene Glycol 3350 Based Bowel Preparation
n=67 Participants
Active control - oral solution, 1 administration
|
BLI800
n=63 Participants
Investigational prep - oral solution, 1 administration
|
|---|---|---|
|
Assessment of Residual Stool - Transverse Colon
Absent
|
82 percentage of participants
|
92 percentage of participants
|
|
Assessment of Residual Stool - Transverse Colon
Small
|
9 percentage of participants
|
8 percentage of participants
|
|
Assessment of Residual Stool - Transverse Colon
Moderate
|
2 percentage of participants
|
0 percentage of participants
|
|
Assessment of Residual Stool - Transverse Colon
Excess
|
2 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 daysThe blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Outcome measures
| Measure |
Polyethylene Glycol 3350 Based Bowel Preparation
n=67 Participants
Active control - oral solution, 1 administration
|
BLI800
n=63 Participants
Investigational prep - oral solution, 1 administration
|
|---|---|---|
|
Assessment of Residual Stool - Descending Colon
Absent
|
84 percentage of participants
|
92 percentage of participants
|
|
Assessment of Residual Stool - Descending Colon
Small
|
9 percentage of participants
|
8 percentage of participants
|
|
Assessment of Residual Stool - Descending Colon
Moderate
|
2 percentage of participants
|
0 percentage of participants
|
|
Assessment of Residual Stool - Descending Colon
Excess
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 daysThe blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Outcome measures
| Measure |
Polyethylene Glycol 3350 Based Bowel Preparation
n=67 Participants
Active control - oral solution, 1 administration
|
BLI800
n=63 Participants
Investigational prep - oral solution, 1 administration
|
|---|---|---|
|
Assessment of Residual Stool - Sigmoid Colon/Rectum
Absent
|
81 percentage of participants
|
94 percentage of participants
|
|
Assessment of Residual Stool - Sigmoid Colon/Rectum
Small
|
10 percentage of participants
|
5 percentage of participants
|
|
Assessment of Residual Stool - Sigmoid Colon/Rectum
Moderate
|
5 percentage of participants
|
1 percentage of participants
|
|
Assessment of Residual Stool - Sigmoid Colon/Rectum
Excess
|
3 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 daysThe blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Outcome measures
| Measure |
Polyethylene Glycol 3350 Based Bowel Preparation
n=67 Participants
Active control - oral solution, 1 administration
|
BLI800
n=63 Participants
Investigational prep - oral solution, 1 administration
|
|---|---|---|
|
Assessment of Residual Fluid - Cecum
Absent
|
15 percentage of participants
|
43 percentage of participants
|
|
Assessment of Residual Fluid - Cecum
Small
|
63 percentage of participants
|
44 percentage of participants
|
|
Assessment of Residual Fluid - Cecum
Moderate
|
15 percentage of participants
|
13 percentage of participants
|
|
Assessment of Residual Fluid - Cecum
Excess
|
2 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 daysThe blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Outcome measures
| Measure |
Polyethylene Glycol 3350 Based Bowel Preparation
n=67 Participants
Active control - oral solution, 1 administration
|
BLI800
n=63 Participants
Investigational prep - oral solution, 1 administration
|
|---|---|---|
|
Assessment of Residual Fluid - Ascending Colon
Absent
|
36 percentage of participants
|
64 percentage of participants
|
|
Assessment of Residual Fluid - Ascending Colon
Small
|
43 percentage of participants
|
36 percentage of participants
|
|
Assessment of Residual Fluid - Ascending Colon
Moderate
|
15 percentage of participants
|
0 percentage of participants
|
|
Assessment of Residual Fluid - Ascending Colon
Excess
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 daysThe blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Outcome measures
| Measure |
Polyethylene Glycol 3350 Based Bowel Preparation
n=67 Participants
Active control - oral solution, 1 administration
|
BLI800
n=63 Participants
Investigational prep - oral solution, 1 administration
|
|---|---|---|
|
Assessment of Residual Fluid - Transverse Colon
Absent
|
49 percentage of participants
|
68 percentage of participants
|
|
Assessment of Residual Fluid - Transverse Colon
Small
|
30 percentage of participants
|
32 percentage of participants
|
|
Assessment of Residual Fluid - Transverse Colon
Moderate
|
13 percentage of participants
|
0 percentage of participants
|
|
Assessment of Residual Fluid - Transverse Colon
Excess
|
12 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 daysThe blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Outcome measures
| Measure |
Polyethylene Glycol 3350 Based Bowel Preparation
n=67 Participants
Active control - oral solution, 1 administration
|
BLI800
n=63 Participants
Investigational prep - oral solution, 1 administration
|
|---|---|---|
|
Assessment of Residual Fluid - Descending Colon
Absent
|
39 percentage of participants
|
67 percentage of participants
|
|
Assessment of Residual Fluid - Descending Colon
Small
|
48 percentage of participants
|
27 percentage of participants
|
|
Assessment of Residual Fluid - Descending Colon
Moderate
|
8 percentage of participants
|
6 percentage of participants
|
|
Assessment of Residual Fluid - Descending Colon
Excess
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 daysThe blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Outcome measures
| Measure |
Polyethylene Glycol 3350 Based Bowel Preparation
n=67 Participants
Active control - oral solution, 1 administration
|
BLI800
n=63 Participants
Investigational prep - oral solution, 1 administration
|
|---|---|---|
|
Assessment of Residual Fluid - Sigmoid Colon/Rectum
Absent
|
48 percentage of participants
|
64 percentage of participants
|
|
Assessment of Residual Fluid - Sigmoid Colon/Rectum
Small
|
42 percentage of participants
|
32 percentage of participants
|
|
Assessment of Residual Fluid - Sigmoid Colon/Rectum
Moderate
|
8 percentage of participants
|
5 percentage of participants
|
|
Assessment of Residual Fluid - Sigmoid Colon/Rectum
Excess
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 daysExpected preparation related symptoms of Abdominal Cramping, Abdominal Bloating, Nausea and Overall discomfort were rated by each subject from 1 - 5 (1=none, 2=mild, 3=bothersome, 4=distressing, 5=severely distressing).
Outcome measures
| Measure |
Polyethylene Glycol 3350 Based Bowel Preparation
n=67 Participants
Active control - oral solution, 1 administration
|
BLI800
n=63 Participants
Investigational prep - oral solution, 1 administration
|
|---|---|---|
|
Subject Symptom Scores
Cramping
|
1.21 units on a scale
Standard Deviation 0.45
|
1.33 units on a scale
Standard Deviation 0.60
|
|
Subject Symptom Scores
Stomach bloating
|
1.62 units on a scale
Standard Deviation 0.84
|
1.33 units on a scale
Standard Deviation 0.54
|
|
Subject Symptom Scores
Nausea
|
1.82 units on a scale
Standard Deviation 1.08
|
1.54 units on a scale
Standard Deviation 0.71
|
|
Subject Symptom Scores
Overall discomfort
|
1.77 units on a scale
Standard Deviation 0.94
|
1.65 units on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: up to 15 daysMean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: blood urea nitrogen, calcium, creatinine, phosphorus. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw.
Outcome measures
| Measure |
Polyethylene Glycol 3350 Based Bowel Preparation
n=67 Participants
Active control - oral solution, 1 administration
|
BLI800
n=63 Participants
Investigational prep - oral solution, 1 administration
|
|---|---|---|
|
Mean Change in Serum Chemistry (mg/dL)
Blood Urea Nitrogen
|
-3.95 mg/dL
Standard Deviation 3.3
|
-3.78 mg/dL
Standard Deviation 3.5
|
|
Mean Change in Serum Chemistry (mg/dL)
Calcium
|
-0.24 mg/dL
Standard Deviation 0.45
|
-0.19 mg/dL
Standard Deviation 0.49
|
|
Mean Change in Serum Chemistry (mg/dL)
Creatinine
|
0.02 mg/dL
Standard Deviation 0.09
|
0.01 mg/dL
Standard Deviation 0.1
|
|
Mean Change in Serum Chemistry (mg/dL)
Phosphorus
|
-0.10 mg/dL
Standard Deviation 0.53
|
-0.18 mg/dL
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: up to 15 daysMean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: bicarbonate, chloride, magnesium, potassium, sodium. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw.
Outcome measures
| Measure |
Polyethylene Glycol 3350 Based Bowel Preparation
n=67 Participants
Active control - oral solution, 1 administration
|
BLI800
n=63 Participants
Investigational prep - oral solution, 1 administration
|
|---|---|---|
|
Mean Change in Serum Chemistry (mEq/L)
Chloride
|
0.66 mEq/L
Standard Deviation 2.4
|
-0.37 mEq/L
Standard Deviation 2.5
|
|
Mean Change in Serum Chemistry (mEq/L)
Bicarbonate
|
-0.81 mEq/L
Standard Deviation 2.0
|
-1.76 mEq/L
Standard Deviation 2.0
|
|
Mean Change in Serum Chemistry (mEq/L)
Magnesium
|
-0.04 mEq/L
Standard Deviation 0.11
|
0.04 mEq/L
Standard Deviation 0.13
|
|
Mean Change in Serum Chemistry (mEq/L)
Potassium
|
-0.16 mEq/L
Standard Deviation 0.47
|
0.03 mEq/L
Standard Deviation 0.64
|
|
Mean Change in Serum Chemistry (mEq/L)
Sodium
|
0.36 mEq/L
Standard Deviation 2.2
|
0.09 mEq/L
Standard Deviation 2.4
|
Adverse Events
Polyethylene Glycol 3350 Based Bowel Preparation
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
BLI800
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Polyethylene Glycol 3350 Based Bowel Preparation
n=67 participants at risk
Active control - oral solution, 1 administration
|
BLI800
n=63 participants at risk
Investigational prep - oral solution, 1 administration
|
|---|---|---|
|
Gastrointestinal disorders
gastrointestinal hemorrhage
|
1.5%
1/67 • Number of events 1
|
0.00%
0/63
|
Other adverse events
| Measure |
Polyethylene Glycol 3350 Based Bowel Preparation
n=67 participants at risk
Active control - oral solution, 1 administration
|
BLI800
n=63 participants at risk
Investigational prep - oral solution, 1 administration
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
9.0%
6/67 • Number of events 6
|
1.6%
1/63 • Number of events 1
|
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 extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER