Status:
COMPLETED
A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population
Lead Sponsor:
Braintree Laboratories
Conditions:
Colonoscopy
Eligibility:
All Genders
6-16 years
Phase:
PHASE4
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 routin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00425594
Start Date
January 1 2007
End Date
May 1 2007
Last Update
December 27 2007
Active Locations (26)
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1
Birmingham, Alabama, United States, 35233
2
Mobile, Alabama, United States, 36604
3
Tuscaloosa, Alabama, United States, 35406
4
Phoenix, Arizona, United States, 85016