Clinical trial NCT02819323: A Safety and Efficacy Study of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
Official title: A Safety and Efficacy Study of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonoscopy
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2016-06-30
Enrollment: 91
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the safety, tolerance and efficacy of BLI800 to a PEG based preparation prior to colonoscopy in adolescent patients.


Eligibility criteria: Inclusion Criteria:

1. Male or female between the ages of 12 to 16 (inclusive)
2. Undergoing colonoscopy for routinely accepted indications, including (but not limited to):

   * Subjected inflammatory bowel disease (IBD) or IBD follow-up
   * Lower gastrointestinal bleeding
   * Suspected colitis (allergic or other)
   * Abdominal pain
   * Chronic diarrhea
   * Cancer surveillance
   * Anemia of unknown etiology
   * Abnormal endosonography or manometry
   * Evaluation of barium enema results
3. If female, and of child-bearing potential, subject must use an acceptable form of birth control or remain abstinent for the duration of the study.
4. Negative pregnancy test at screening, if applicable
5. In the Investigator's judgment, caregiver is mentally competent to provide informed consent for their child to participate in the study.

Exclusion Criteria:

1. Subjects with known or suspected ileus, impaction, severe ulcerative colitis, acute peritonitis, gastrointestinal obstruction, gastric retention (gastroparesis), bowel perforation, toxic colitis or megacolon.
2. Subjects who had previous significant gastrointestinal surgeries.
3. Subjects with increased risk of bowel perforation, including connective tissue disorders, toxic dilation of the bowel or recent bowel surgery.
4. Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, uncorrected dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
5. Subjects with bleeding disorders and/or impaired platelet function, or neutropenia.
6. Subjects with a prior history of renal, liver or cardiac insufficiency (including congestive heart failure or other significant cardiac abnormality)
7. Subjects with estimated glomerular filtration rate (GFR) below normal range (less than 70 ml/min/1.73m2)
8. Subjects required to take any other oral medication within 3 hours of dosing until completion of both doses.
9. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
10. Subjects with tendency for nausea and/or vomiting, or that have known swallowing disorders.
11. Subjects for whom intake of substances is likely to affect gastrointestinal motility or urinary flow rate.
12. Subjects undergoing colonoscopy for foreign body removal and/or decompression.
13. Subjects with an abnormal ECG result at Visit 1.
14. Subjects who are pregnant or lactating, or intending to become pregnant during the study.
15. Subjects of childbearing potential who refuse a pregnancy test.
16. Subjects with a history of hypersensitivity to any preparation components.
17. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures and history of major medical/psychiatric conditions that would compromise the safety of the study.
18. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
19. Subjects who withdraw consent before completion of Visit 1 procedures.

Primary outcomes:
measure: Number and Percentage of Subjects With Successful Bowel Cleansing
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Braintree Research Site 27
state: Alabama
city: Tucson
country: United States
facility: Braintree Research Site 30
state: Arizona
city: Orange
country: United States
facility: Braintree Research Site 23
state: California
city: San Francisco
country: United States
facility: Braintree Research Site 16
state: California
city: Gainesville
country: United States
facility: Braintree Research Site 5
state: Florida
city: Jacksonville
country: United States
facility: Braintree Research Site 24
state: Florida
city: Orlando
country: United States
facility: Braintree Research Site 21
state: Florida
city: Atlanta
country: United States
facility: Braintree Research Site 2
state: Georgia
city: Chicago
country: United States
facility: Braintree Research Site 13
state: Illinois
city: Park Ridge
country: United States
facility: Braintree Research Site 3
state: Illinois
city: Indianapolis
country: United States
facility: Braintree Research Site 26
state: Indiana
city: Minneapolis
country: United States
facility: Braintree Research Site 25
state: Minnesota
city: Rochester
country: United States
facility: Braintree Research Site 18
state: Minnesota
city: Flowood
country: United States
facility: Braintree Research Site 1
state: Mississippi
city: Bronx
country: United States
facility: Braintree Research Site 32
state: New York
city: Buffalo
country: United States
facility: Braintree Research Site 9
state: New York
city: New York
country: United States
facility: Braintree Research Site 28
state: New York
city: New York
country: United States
facility: Braintree Research Site 19
state: New York
city: Pittsburgh
country: United States
facility: Braintree Research Site 6
state: Pennsylvania
city: Memphis
country: United States
facility: Braintree Research Site 20
state: Tennessee
city: Plano
country: United States
facility: Braintree Research Site 34
state: Texas
city: Salt Lake City
country: United States
facility: Braintree Research Site 22
state: Utah
city: Burlington
country: United States
facility: Braintree Research Site 10
state: Vermont
city: Norfolk
country: United States
facility: Braintree Research Site 17
state: Virginia
city: Roanoke
country: United States
facility: Braintree Research Site 4
state: Virginia
city: Seattle
country: United States
facility: Braintree Research Site 11
state: Washington
city: Milwaukee
country: United States
facility: Braintree Research Site 14
state: Wisconsin
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan
role: STUDY_DIRECTOR
References: