Clinical trial NCT00856843: BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Official title: BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonoscopy
Keywords: colonoscopy
bowel preparation
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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:

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.

Primary outcomes:
measure: Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale
timeFrame: 2 days
Secondary outcomes:
measure: Assessment of Residual Stool - Cecum
timeFrame: 2 days
measure: Assessment of Residual Stool - Ascending Colon
timeFrame: 2 days
measure: Assessment of Residual Stool - Transverse Colon
timeFrame: 2 days
measure: Assessment of Residual Stool - Descending Colon
timeFrame: 2 days
measure: Assessment of Residual Stool - Sigmoid Colon/Rectum
timeFrame: 2 days
measure: Assessment of Residual Fluid - Cecum
timeFrame: 2 days
measure: Assessment of Residual Fluid - Ascending Colon
timeFrame: 2 days
measure: Assessment of Residual Fluid - Transverse Colon
timeFrame: 2 days
measure: Assessment of Residual Fluid - Descending Colon
timeFrame: 2 days
measure: Assessment of Residual Fluid - Sigmoid Colon/Rectum
timeFrame: 2 days
measure: Subject Symptom Scores
timeFrame: 2 days
measure: Mean Change in Serum Chemistry (mg/dL)
timeFrame: up to 15 days
measure: Mean Change in Serum Chemistry (mEq/L)
timeFrame: up to 15 days
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Jupiter
country: United States
facility: Jupiter Research
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: Great Neck
country: United States
facility: Long Island GI Research Group
state: New York
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan, MPH
role: STUDY_DIRECTOR
References:
citation: Rex DK, Di Palma JA, Rodriguez R, McGowan J, Cleveland M. A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest Endosc. 2010 Aug;72(2):328-36. doi: 10.1016/j.gie.2010.03.1054. Epub 2010 Jun 19.