A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population

Completed · Phase 4

Conditions studied: Colonoscopy

In brief

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.

Key facts

Study ID

NCT00425594

Run by

Braintree Laboratories

People needed

150

Starts

2007-01-01

Expected to finish

2007-05-01

Last updated by the study team

2007-12-27

Who can join

Age: 6 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Tuscaloosa, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — San Francisco, California, United States
• Study site — Gainesville, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Park Ridge, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Jackson, Mississippi, United States
• Study site — Omaha, Nebraska, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Morristown, New Jersey, United States
• Study site — Buffalo, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Lancaster, Pennsylvania, United States
• Study site — Columbia, South Carolina, United States
• Study site — Houston, Texas, United States
• Study site — Temple, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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