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

This study has been completed.
Sponsor:
Information provided by:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00425594
First received: January 19, 2007
Last updated: December 20, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Colonoscopy
Drug: HalfLytely and Bisacodyl Tablets - Formulation 1
Drug: HalfLytely and Bisacodyl Tablets - Formulation 2
Drug: NuLYTELY
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population

Resource links provided by NLM:


Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:
  • Efficacy - preparation quality using a 4-point scale

Secondary Outcome Measures:
  • Safety - patient reported preparation related side effects. Pre and post preparation analysis of serum chemistry.

Estimated Enrollment: 150
Study Start Date: January 2007
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00425594

  Show 26 Study Locations
Sponsors and Collaborators
Braintree Laboratories
Investigators
Study Director: John McGowan Braintree Laboratories, Inc.
  More Information

No publications provided

Responsible Party: John McGowan, Clinical Operations Manager, Braintree Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00425594     History of Changes
Other Study ID Numbers: F38-25
Study First Received: January 19, 2007
Last Updated: December 20, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Braintree Laboratories:
colonoscopy
bowel preparation
prep

Additional relevant MeSH terms:
Bisacodyl
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014