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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: HalfLytely and Bisacodyl Tablets - Formulation 1
* Drug: HalfLytely and Bisacodyl Tablets - Formulation 2
* Drug: NuLYTELY


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HalfLytely and Bisacodyl Tablets - Formulation 1|nan|
|Drug: HalfLytely and Bisacodyl Tablets - Formulation 2|nan|
|Drug: NuLYTELY|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - preparation quality using a 4-point scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - patient reported preparation related side effects. Pre and post preparation analysis of serum chemistry. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, bowel preparation, prep