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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00425594
Recruitment Status : Completed
First Posted : January 23, 2007
Last Update Posted : December 27, 2007
Information provided by:
Braintree Laboratories

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.

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population
Study Start Date : January 2007
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: Bisacodyl
U.S. FDA Resources

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00425594

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

Responsible Party: John McGowan, Clinical Operations Manager, Braintree Laboratories, Inc. Identifier: NCT00425594     History of Changes
Other Study ID Numbers: F38-25
First Posted: January 23, 2007    Key Record Dates
Last Update Posted: December 27, 2007
Last Verified: December 2007

Keywords provided by Braintree Laboratories:
bowel preparation

Additional relevant MeSH terms:
Gastrointestinal Agents