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A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population
This study has been completed.
First Received: January 19, 2007   Last Updated: December 20, 2007   History of Changes
Sponsor: Braintree Laboratories
Information provided by: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT00425594
  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 IV

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
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

  Hide Study Locations
Locations
United States, Alabama
Mobile, Alabama, United States, 36604
Tuscaloosa, Alabama, United States, 35406
Birmingham, Alabama, United States, 35233
United States, Arizona
Phoenix, Arizona, United States, 85016
United States, Arkansas
Little Rock, Arkansas, United States, 72202
United States, California
San Francisco, California, United States, 94143
United States, Florida
Gainesville, Florida, United States, 32610
Orlando, Florida, United States, 32801
United States, Illinois
Park Ridge, Illinois, United States, 60068
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
Jackson, Mississippi, United States, 39216
United States, Nebraska
Omaha, Nebraska, United States, 68198
United States, Nevada
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Morristown, New Jersey, United States, 07962
United States, New York
Buffalo, New York, United States, 14222
United States, Ohio
Columbus, Ohio, United States, 43205
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Lancaster, Pennsylvania, United States, 17604
United States, South Carolina
Columbia, South Carolina, United States, 29203
United States, Texas
Houston, Texas, United States, 77030
Temple, Texas, United States, 76508
United States, Utah
Salt Lake City, Utah, United States, 84113
United States, Vermont
Burlington, Vermont, United States, 05401
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Braintree Laboratories
Investigators
Study Director: John McGowan Braintree Laboratories, Inc.
  More Information

No publications provided

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

Keywords provided by Braintree Laboratories:
colonoscopy
bowel preparation
prep

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

ClinicalTrials.gov processed this record on November 27, 2009