BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00856843

Enrollment

136

Registered

2009-03-06

Start date

2009-02-28

Completion date

Unknown

Last updated

2010-11-10

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

Conditions

Colonoscopy

Keywords

colonoscopy, bowel preparation

Brief summary

To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before colonoscopic examination in adult subjects.

Interventions

DRUGBLI800

Solution for oral administration prior to colonoscopy

DRUGPolyethylene glycol 3350 based bowel preparation

Solution for oral administration prior to colonoscopy

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

Inclusion criteria

1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication. 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 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 who had previous gastrointestinal surgeries. 3. Subjects with known or suspected electrolyte abnormalities such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors. 4. Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results. 5. Subjects with impaired consciousness that predisposes them to pulmonary aspiration. 6. Subjects undergoing colonoscopy for foreign body removal and decompression. 7. Subjects who are pregnant or lactating, or intending to become pregnant during the study. 8. Subjects of childbearing potential who refuse a pregnancy test. 9. Subjects allergic to any preparation components 10. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures. 11. 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: Percentage of Patients With Successful Preparations Based on a 4 Point Scale	2 days	Blinded colonoscopists rated cleansing quality as either Excellent, Good, Fair or Poor. Scores of Excellent or Good were considered Successful preparations.

Secondary

Measure	Time frame	Description
Assessment of Residual Stool - Ascending Colon	2 days	The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Assessment of Residual Stool - Transverse Colon	2 days	The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Assessment of Residual Stool - Descending Colon	2 days	The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Assessment of Residual Stool - Sigmoid Colon/Rectum	2 days	The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Assessment of Residual Fluid - Cecum	2 days	The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Assessment of Residual Fluid - Ascending Colon	2 days	The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Assessment of Residual Stool - Cecum	2 days	The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Assessment of Residual Fluid - Descending Colon	2 days	The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Assessment of Residual Fluid - Sigmoid Colon/Rectum	2 days	The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Subject Symptom Scores	2 days	Expected 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).
Mean Change in Serum Chemistry (mg/dL)	up to 15 days	Mean 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.
Mean Change in Serum Chemistry (mEq/L)	up to 15 days	Mean 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.
Assessment of Residual Fluid - Transverse Colon	2 days	The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Polyethylene Glycol 3350 Based Bowel Preparation Active control - oral solution, 1 administration	68
BLI800 Investigational prep - oral solution, 1 administration	68
Total	136

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lack of Efficacy	1	0
Overall Study	Withdrawal by Subject	1	5

Baseline characteristics

Characteristic	BLI800	Polyethylene Glycol 3350 Based Bowel Preparation	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	18 Participants	15 Participants	33 Participants
Age, Categorical Between 18 and 65 years	50 Participants	53 Participants	103 Participants
Age Continuous	57.7 years STANDARD_DEVIATION 10.8	56.7 years STANDARD_DEVIATION 11	57.2 years STANDARD_DEVIATION 10.8
Region of Enrollment United States	68 participants	68 participants	136 participants
Sex: Female, Male Female	36 Participants	31 Participants	67 Participants
Sex: Female, Male Male	32 Participants	37 Participants	69 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	6 / 67	1 / 63
serious Total, serious adverse events	1 / 67	0 / 63

Outcome results

Primary

Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale

Blinded colonoscopists rated cleansing quality as either Excellent, Good, Fair or Poor. Scores of Excellent or Good were considered Successful preparations.

Time frame: 2 days

Arm	Measure	Value (NUMBER)
Polyethylene Glycol 3350 Based Bowel Preparation	Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale	89.6 percentage of participants
BLI800	Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale	98.4 percentage of participants

p-value: 0.03895% CI: [0.9, 16.8]Chi-squared

Secondary

Assessment of Residual Fluid - Ascending Colon

The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.

Time frame: 2 days

Arm	Measure	Group	Value (NUMBER)
Polyethylene Glycol 3350 Based Bowel Preparation	Assessment of Residual Fluid - Ascending Colon	Absent	36 percentage of participants
Polyethylene Glycol 3350 Based Bowel Preparation	Assessment of Residual Fluid - Ascending Colon	Small	43 percentage of participants
Polyethylene Glycol 3350 Based Bowel Preparation	Assessment of Residual Fluid - Ascending Colon	Moderate	15 percentage of participants
Polyethylene Glycol 3350 Based Bowel Preparation	Assessment of Residual Fluid - Ascending Colon	Excess	0 percentage of participants
BLI800	Assessment of Residual Fluid - Ascending Colon	Excess	0 percentage of participants
BLI800	Assessment of Residual Fluid - Ascending Colon	Absent	64 percentage of participants
BLI800	Assessment of Residual Fluid - Ascending Colon	Moderate	0 percentage of participants
BLI800	Assessment of Residual Fluid - Ascending Colon	Small	36 percentage of participants

p-value: <0.001Chi-squared

Secondary

Assessment of Residual Fluid - Cecum

The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.

Time frame: 2 days

Arm	Measure	Group	Value (NUMBER)
Polyethylene Glycol 3350 Based Bowel Preparation	Assessment of Residual Fluid - Cecum	Absent	15 percentage of participants
Polyethylene Glycol 3350 Based Bowel Preparation	Assessment of Residual Fluid - Cecum	Small	63 percentage of participants
Polyethylene Glycol 3350 Based Bowel Preparation	Assessment of Residual Fluid - Cecum	Moderate	15 percentage of participants
Polyethylene Glycol 3350 Based Bowel Preparation	Assessment of Residual Fluid - Cecum	Excess	2 percentage of participants
BLI800	Assessment of Residual Fluid - Cecum	Excess	0 percentage of participants
BLI800	Assessment of Residual Fluid - Cecum	Absent	43 percentage of participants
BLI800	Assessment of Residual Fluid - Cecum	Moderate	13 percentage of participants
BLI800	Assessment of Residual Fluid - Cecum	Small	44 percentage of participants

p-value: 0.004Chi-squared

Secondary

Assessment of Residual Fluid - Descending Colon

The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.

Time frame: 2 days

Arm	Measure	Group	Value (NUMBER)
Polyethylene Glycol 3350 Based Bowel Preparation	Assessment of Residual Fluid - Descending Colon	Absent	39 percentage of participants
Polyethylene Glycol 3350 Based Bowel Preparation	Assessment of Residual Fluid - Descending Colon	Small	48 percentage of participants
Polyethylene Glycol 3350 Based Bowel Preparation	Assessment of Residual Fluid - Descending Colon	Moderate	8 percentage of participants
Polyethylene Glycol 3350 Based Bowel Preparation	Assessment of Residual Fluid - Descending Colon	Excess	0 percentage of participants
BLI800	Assessment of Residual Fluid - Descending Colon	Excess	0 percentage of participants
BLI800	Assessment of Residual Fluid - Descending Colon	Absent	67 percentage of participants
BLI800	Assessment of Residual Fluid - Descending Colon	Moderate	6 percentage of participants
BLI800	Assessment of Residual Fluid - Descending Colon	Small	27 percentage of participants

p-value: 0.013Chi-squared

Secondary

Assessment of Residual Fluid - Sigmoid Colon/Rectum

The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.

Time frame: 2 days

Arm	Measure	Group	Value (NUMBER)
Polyethylene Glycol 3350 Based Bowel Preparation	Assessment of Residual Fluid - Sigmoid Colon/Rectum	Small	42 percentage of participants
Polyethylene Glycol 3350 Based Bowel Preparation	Assessment of Residual Fluid - Sigmoid Colon/Rectum	Excess	0 percentage of participants
Polyethylene Glycol 3350 Based Bowel Preparation	Assessment of Residual Fluid - Sigmoid Colon/Rectum	Moderate	8 percentage of participants
Polyethylene Glycol 3350 Based Bowel Preparation	Assessment of Residual Fluid - Sigmoid Colon/Rectum	Absent	48 percentage of participants
BLI800	Assessment of Residual Fluid - Sigmoid Colon/Rectum	Absent	64 percentage of participants
BLI800	Assessment of Residual Fluid - Sigmoid Colon/Rectum	Small	32 percentage of participants
BLI800	Assessment of Residual Fluid - Sigmoid Colon/Rectum	Moderate	5 percentage of participants
BLI800	Assessment of Residual Fluid - Sigmoid Colon/Rectum	Excess	0 percentage of participants

p-value: 0.283Chi-squared

Secondary

Assessment of Residual Fluid - Transverse Colon

The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.

Time frame: 2 days

Arm	Measure	Group	Value (NUMBER)
Polyethylene Glycol 3350 Based Bowel Preparation	Assessment of Residual Fluid - Transverse Colon	Absent	49 percentage of participants
Polyethylene Glycol 3350 Based Bowel Preparation	Assessment of Residual Fluid - Transverse Colon	Small	30 percentage of participants
Polyethylene Glycol 3350 Based Bowel Preparation	Assessment of Residual Fluid - Transverse Colon	Moderate	13 percentage of participants
Polyethylene Glycol 3350 Based Bowel Preparation	Assessment of Residual Fluid - Transverse Colon	Excess	12 percentage of participants
BLI800	Assessment of Residual Fluid - Transverse Colon	Excess	0 percentage of participants
BLI800	Assessment of Residual Fluid - Transverse Colon	Absent	68 percentage of participants
BLI800	Assessment of Residual Fluid - Transverse Colon	Moderate	0 percentage of participants
BLI800	Assessment of Residual Fluid - Transverse Colon	Small	32 percentage of participants

p-value: 0.005Chi-squared

Secondary