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

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00425594
• Other study ID #: F38-25
• Status: Completed
• Phase: Phase 4
• First received: January 19, 2007
• Last updated: December 20, 2007
• Start date: January 2007
• Est. completion date: May 2007

Study information

• Verified date: December 2007
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• HalfLytely and Bisacodyl Tablets - Formulation 1

• HalfLytely and Bisacodyl Tablets - Formulation 2

• NuLYTELY

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy - preparation quality using a 4-point scale
Secondary	Safety - patient reported preparation related side effects. Pre and post preparation analysis of serum chemistry.