Status:
COMPLETED
F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Lead Sponsor:
Braintree Laboratories
Conditions:
Colonoscopy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.
Eligibility Criteria
Inclusion
- Male or female outpatients who are undergoing colonoscopy for a routinely accepted indications:
- 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
- Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
- Subjects with impaired consciousness that predisposes them to pulmonary aspiration
- Subjects who are undergoing colonoscopy for foreign body removal and decompression
- Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics
- Subjects who are taking drugs that may affect electrolyte levels with the exception of routine diuretics
- Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
- Subjects who are pregnant or lactating, or intending to become pregnant during the study
- Subjects of childbearing potential who refuse a pregnancy test
- Subjects who are 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 clinical, surgical, drug, or device study within the past 30 days
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT00857272
Start Date
February 1 2009
Last Update
October 5 2010
Active Locations (6)
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1
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
2
Advanced Clinical Research Institute
Orange, California, United States, 92869
3
Medical Associates Research Group
San Diego, California, United States, 92123
4
United Medical Research
New Smyrna Beach, Florida, United States, 32168