BLI800-480: A Safety and Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/30/2013
Start Date:December 2012
Contact:John McGowan, MPH
Email:jmcgowan@braintreelabs.com
Phone:781-843-2202

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To compare the safety, tolerance and efficacy of SUPREP Bowel Prep Kit to an FDA approved
control as bowel preparations prior to colonoscopy in adult patients.


Inclusion Criteria:

Male or female outpatients who are undergoing colonoscopy for a routinely accepted
indication.

At least 18 years of age

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 significant gastrointestinal surgeries

Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with
clinically significant electrolyte abnormalities based on screening laboratory results,
such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia,
dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme
(ACE) inhibitors.

Subjects with a prior history of renal, liver or cardiac insufficiency

Subjects with impaired consciousness that predisposes them to pulmonary aspiration.

Subjects undergoing colonoscopy for foreign body removal and/or 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.

Subjects who withdraw consent before completion of Visit 1 procedures.
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325 Winding River Lane
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3100 Duraleigh Road
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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Brockton, Massachusetts 02302
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Franklin, Tennessee 37067
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Great Neck, New York 11023
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545 Barnhill Dr
Indianapolis, Indiana 46201
(317) 274-8157
Indiana University Medical Center Indiana University Health is Indiana
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Jackson, Mississippi 39202
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307 N University Blvd
Mobile, Alabama 36688
(251) 460-6101
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