F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Information source: Braintree Laboratories
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colonoscopy
Intervention: PEG electrolyte lavage solution + bisacodyl - reformulation (Drug); PEG electrolyte lavage solution + bisacodyl (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Braintree Laboratories Official(s) and/or principal investigator(s): John McGowan, MPH, Study Director, Affiliation: Braintree Laboratories, Inc.
Summary
To compare the safety and efficacy of 2 different bowel cleansing preparations prior to
colonoscopy in adult subjects.
Clinical Details
Official title: F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted
indications:
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, gastrointestinal obstruction, gastric
retention, bowel perforation, toxic colitis, or toxic megacolon
2. Subjects with impaired consciousness that predisposes them to pulmonary aspiration
3. Subjects who are undergoing colonoscopy for foreign body removal and decompression
4. Subjects with pre-existing electrolyte disturbances, such as dehydration, or those
secondary to the use of diuretics
5. Subjects who are taking drugs that may affect electrolyte levels with the exception
of routine diuretics
6. Subjects with known clinically significant electrolyte abnormalities such as
hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
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 who are 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 clinical, surgical, drug, or
device study within the past 30 days
Locations and Contacts
Advanced Clinical Research Institute, Anaheim, California 92801, United States
Advanced Clinical Research Institute, Orange, California 92869, United States
Medical Associates Research Group, San Diego, California 92123, United States
United Medical Research, New Smyrna Beach, Florida 32168, United States
Maryland Digestive Disease Research, Laurel, Maryland 20707, United States
Franklin Gastroenterology, Franklin, Tennessee 37067, United States
Additional Information
Starting date: February 2009
Last updated: September 29, 2010
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