Clinical trial NCT00857272: F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Official title: F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonoscopy
Keywords: colonoscopy
bowel preparation
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.


Eligibility 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

Primary outcomes:
measure: Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale
timeFrame: during colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Orange
country: United States
facility: Advanced Clinical Research Institute
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: New Smyrna Beach
country: United States
facility: United Medical Research
state: Florida
city: Laurel
country: United States
facility: Maryland Digestive Disease Research
state: Maryland
city: Franklin
country: United States
facility: Franklin Gastroenterology
state: Tennessee
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan, MPH
role: STUDY_DIRECTOR
References: