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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single
  • Study Primary Completion Date: May 2007

Interventions

  • Drug: HalfLytely and Bisacodyl Tablets – Formulation 1
  • Drug: HalfLytely and Bisacodyl Tablets – Formulation 2
  • Drug: NuLYTELY

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy – preparation quality using a 4-point scale

Secondary Measures

  • Safety – patient reported preparation related side effects. Pre and post preparation analysis of serum chemistry.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Braintree Laboratories
  • Provider of Information About this Clinical Study
    • John McGowan, Clinical Operations Manager, Braintree Laboratories, Inc.
  • Overall Official(s)
    • John McGowan, Study Director, Braintree Laboratories, Inc.

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