Clinical trial NCT00425594: A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population
Official title: A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonoscopy
Keywords: colonoscopy
bowel preparation
prep
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2007-01-23
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Efficacy - preparation quality using a 4-point scale
Secondary outcomes:
measure: Safety - patient reported preparation related side effects. Pre and post preparation analysis of serum chemistry.
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Tuscaloosa
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: San Francisco
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Park Ridge
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Boston
country: United States
state: Massachusetts
city: Minneapolis
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Morristown
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Lancaster
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Houston
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan
role: STUDY_DIRECTOR
References: