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 |
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.
We found this trial at
10
sites
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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Indiana University Medical Center Indiana University Health is Indiana
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University of South Alabama "University of South Alabama is a public institution that was founded...
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