Colonoscopy
Conditions
Keywords
colonoscopy, bowel preparation, prep
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.
Interventions
DRUGHalfLytely and Bisacodyl Tablets - Formulation 1
DRUGHalfLytely and Bisacodyl Tablets - Formulation 2
DRUGNuLYTELY
Sponsors
Braintree Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy - preparation quality using a 4-point scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety - patient reported preparation related side effects. Pre and post preparation analysis of serum chemistry. | — |
Countries
United States
Outcome results
None listed