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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

Page last updated: August 23, 2015

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