A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population
NCT ID: NCT00425594
Last Updated: 2007-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
150 participants
INTERVENTIONAL
2007-01-31
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
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HalfLytely and Bisacodyl Tablets - Formulation 1
HalfLytely and Bisacodyl Tablets - Formulation 2
NuLYTELY
Eligibility Criteria
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Inclusion Criteria
* Evaluation of BE results
* Endosonography
* Blood in stool
* Anemia of unknown etiology
* Abdominal Pain
* Polypectomy
* Unknown diarrhea or constipation etiology
* Inflammatory bowel disease
* Between 6 and 16 years of age at screening.
* 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 (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse).
* Negative urine pregnancy test at screening, if applicable
* In the investigator's judgment, parent/guardian is mentally competent to provide informed consent to participate in the study.
Exclusion Criteria
* Subjects impacted at screening
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
* Subjects who are undergoing colonoscopy for foreign body removal and decompression
* Subjects with known difficulties for swallowing tablets
* 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.
* Any condition in parent/guardian associated with poor subject compliance (e.g., substance abuse); inability of parent/guardian to return for scheduled visits with their child.
6 Years
16 Years
ALL
No
Sponsors
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Braintree Laboratories
INDUSTRY
Responsible Party
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Braintree Laboratories, Inc.
Principal Investigators
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John McGowan
Role: STUDY_DIRECTOR
Braintree Laboratories, Inc.
Locations
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Birmingham, Alabama, United States
Mobile, Alabama, United States
Tuscaloosa, Alabama, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
San Francisco, California, United States
Gainesville, Florida, United States
Orlando, Florida, United States
Park Ridge, Illinois, United States
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Jackson, Mississippi, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Morristown, New Jersey, United States
Buffalo, New York, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Lancaster, Pennsylvania, United States
Columbia, South Carolina, United States
Houston, Texas, United States
Temple, Texas, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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F38-25
Identifier Type: -
Identifier Source: org_study_id