A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population
1 other identifier
interventional
150
1 country
26
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2007
Shorter than P25 for phase_4
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 19, 2007
CompletedFirst Posted
Study publicly available on registry
January 23, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedDecember 27, 2007
December 1, 2007
4 months
January 19, 2007
December 20, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy - preparation quality using a 4-point scale
Secondary Outcomes (1)
Safety - patient reported preparation related side effects. Pre and post preparation analysis of serum chemistry.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Unknown Facility
Birmingham, Alabama, 35233, United States
Unknown Facility
Mobile, Alabama, 36604, United States
Unknown Facility
Tuscaloosa, Alabama, 35406, United States
Unknown Facility
Phoenix, Arizona, 85016, United States
Unknown Facility
Little Rock, Arkansas, 72202, United States
Unknown Facility
San Francisco, California, 94143, United States
Unknown Facility
Gainesville, Florida, 32610, United States
Unknown Facility
Orlando, Florida, 32801, United States
Unknown Facility
Park Ridge, Illinois, 60068, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Minneapolis, Minnesota, 55455, United States
Unknown Facility
Jackson, Mississippi, 39216, United States
Unknown Facility
Omaha, Nebraska, 68198, United States
Unknown Facility
Las Vegas, Nevada, 89109, United States
Unknown Facility
Morristown, New Jersey, 07962, United States
Unknown Facility
Buffalo, New York, 14222, United States
Unknown Facility
Cleveland, Ohio, 44106, United States
Unknown Facility
Columbus, Ohio, 43205, United States
Unknown Facility
Lancaster, Pennsylvania, 17604, United States
Unknown Facility
Columbia, South Carolina, 29203, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Temple, Texas, 76508, United States
Unknown Facility
Salt Lake City, Utah, 84113, United States
Unknown Facility
Burlington, Vermont, 05401, United States
Unknown Facility
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
John McGowan
Braintree Laboratories, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 19, 2007
First Posted
January 23, 2007
Study Start
January 1, 2007
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
December 27, 2007
Record last verified: 2007-12