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

Braintree Laboratories

Status and phase

Completed

Phase 4

Conditions

Colonoscopy

Treatments

Drug: NuLYTELY

Drug: HalfLytely and Bisacodyl Tablets - Formulation 2

Drug: HalfLytely and Bisacodyl Tablets - Formulation 1

Study type

Interventional

Funder types

Industry

Identifiers

NCT00425594

F38-25

Details and patient eligibility

About

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.

Sex

All

Ages

6 to 16 years old

Volunteers

No Healthy Volunteers

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.