A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population
Information source: Braintree Laboratories
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colonoscopy
Intervention: HalfLytely and Bisacodyl Tablets - Formulation 1 (Drug); HalfLytely and Bisacodyl Tablets - Formulation 2 (Drug); NuLYTELY (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Braintree Laboratories Official(s) and/or principal investigator(s):
John McGowan, Study Director, Affiliation: Braintree Laboratories, Inc.
Summary
This randomized, parallel, multi-center, single-blind study is designed to compare the safety
and efficacy of 3 bowel preparations in pediatric subjects scheduled to undergo a colonoscopy
for a routinely accepted indication.
Clinical Details
Official title: A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Primary outcome: Efficacy - preparation quality using a 4-point scale
Secondary outcome: Safety - patient reported preparation related side effects. Pre and post preparation analysis of serum chemistry.
Eligibility
Minimum age: 6 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female patients who are undergoing colonoscopy for a routinely accepted
indication, including:
- 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 with known or suspected ileus, gastrointestinal obstruction, gastric
retention, bowel perforation, toxic colitis, or toxic megacolon
- 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.
Locations and Contacts
Mobile, Alabama 36604, United States
Tuscaloosa, Alabama 35406, United States
Birmingham, Alabama 35233, United States
Phoenix, Arizona 85016, United States
Little Rock, Arkansas 72202, United States
San Francisco, California 94143, United States
Gainesville, Florida 32610, United States
Orlando, Florida 32801, United States
Park Ridge, Illinois 60068, United States
Indianapolis, Indiana 46202, United States
Boston, Massachusetts 02114, United States
Minneapolis, Minnesota 55455, United States
Jackson, Mississippi 39216, United States
Omaha, Nebraska 68198, United States
Las Vegas, Nevada 89109, United States
Morristown, New Jersey 07962, United States
Buffalo, New York 14222, United States
Columbus, Ohio 43205, United States
Cleveland, Ohio 44106, United States
Lancaster, Pennsylvania 17604, United States
Columbia, South Carolina 29203, United States
Houston, Texas 77030, United States
Temple, Texas 76508, United States
Salt Lake City, Utah 84113, United States
Burlington, Vermont 05401, United States
Milwaukee, Wisconsin 53226, United States
Additional Information
Starting date: January 2007
Ending date: May 2007
Last updated: December 20, 2007
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