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

Phase 4

Completed

• Conditions: Colonoscopy

• Registration Number: NCT00425594
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-19
• Study First Submitted QC: 2007-01-22
• Study First Posted: 2007-01-23
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-20
• Last Update Posted: 2007-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy - preparation quality using a 4-point scale

Secondary Outcome Measures

Name	Time	Method
Safety - patient reported preparation related side effects. Pre and post preparation analysis of serum chemistry.