Phase 3 N=136 Randomized Single-blind Treatment

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

Colonoscopy

Bottom Line

View on ClinicalTrials.gov: NCT00856843 ↗

Enrolled (actual)

136

Serious AEs

0.8%

Results posted

Nov 2010

Primary outcome: Primary: Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale — 89.6; 98.4 percentage of participants — p=0.038

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: BLI800 (Drug); Polyethylene glycol 3350 based bowel preparation (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Braintree Laboratories
Primary completion: May 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale	89.6; 98.4	0.038 sig
SECONDARY Assessment of Residual Stool - Cecum	67; 91; 22; 9; 5; 0	0.010 sig
SECONDARY Assessment of Residual Stool - Ascending Colon	69; 91; 24; 9; 2; 0	0.020 sig
SECONDARY Assessment of Residual Stool - Transverse Colon	82; 92; 9; 8; 2; 0	0.644
SECONDARY Assessment of Residual Stool - Descending Colon	84; 92; 9; 8; 2; 0	0.763
SECONDARY Assessment of Residual Stool - Sigmoid Colon/Rectum	81; 94; 10; 5; 5; 1	0.173
SECONDARY Assessment of Residual Fluid - Cecum	15; 43; 63; 44; 15; 13	0.004 sig
SECONDARY Assessment of Residual Fluid - Ascending Colon	36; 64; 43; 36; 15; 0	<0.001 sig
SECONDARY Assessment of Residual Fluid - Transverse Colon	49; 68; 30; 32; 13; 0	0.005 sig
SECONDARY Assessment of Residual Fluid - Descending Colon	39; 67; 48; 27; 8; 6	0.013 sig
SECONDARY Assessment of Residual Fluid - Sigmoid Colon/Rectum	48; 64; 42; 32; 8; 5	0.283
SECONDARY Subject Symptom Scores	1.21; 1.33; 1.62; 1.33; 1.82; 1.54	—
SECONDARY Mean Change in Serum Chemistry (mg/dL)	-3.95; -3.78; -0.24; -0.19; 0.02; 0.01	—
SECONDARY Mean Change in Serum Chemistry (mEq/L)	-0.81; -1.76; 0.66; -0.37; -0.04; 0.04	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
At least 18 years of age
Otherwise in good health, as determined by physical exam and medical history
If female, and of child-bearing potential, is using an acceptable form of birth control
Negative urine pregnancy test at screening, if applicable
In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria

Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
Subjects who had previous gastrointestinal surgeries.
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.
Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
Subjects undergoing colonoscopy for foreign body removal and decompression.
Subjects who are pregnant or lactating, or intending to become pregnant during the study.
Subjects of childbearing potential who refuse a pregnancy test.
Subjects allergic to any preparation components
Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00856843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.