Status:
COMPLETED
A Safety Study of 3 Different Bowel Cleansing Preparations
Lead Sponsor:
Braintree Laboratories
Conditions:
Colonoscopy
Bowel Preparation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to compare the safety, tolerance and efficacy of BLI800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonos...
Eligibility Criteria
Inclusion
- 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
- 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 who have uncontrolled clinically significant pre-existing electrolyte disturbances.
- Subjects with severe liver or renal insufficiency.
- Subjects with a history of congestive heart failure or other clinically significant cardiac abnormality.
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2013
Estimated Enrollment :
541 Patients enrolled
Trial Details
Trial ID
NCT01501513
Start Date
December 1 2011
End Date
March 4 2013
Last Update
January 17 2024
Active Locations (17)
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1
University of South Alabama
Mobile, Alabama, United States, 36693
2
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
3
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
4
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256