A Safety and Efficacy Study of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy

Colonoscopy Clinical Trial

Official title:

A Safety and Efficacy Study of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819323
• Other study ID #: BLI800-502
• Status: Completed
• Phase: Phase 3
• Start date: June 2016
• Est. completion date: March 27, 2018

Study information

• Verified date: April 2021
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: March 27, 2018
• Est. primary completion date: March 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• PEG-ELS
polyethylene glycol based bowel preparation
• BLI800
BLI800 bowel preparation

Locations

Country	Name	City	State
United States	Braintree Research Site 2	Atlanta	Georgia
United States	Braintree Research Site 32	Bronx	New York
United States	Braintree Research Site 9	Buffalo	New York
United States	Braintree Research Site 10	Burlington	Vermont
United States	Braintree Research Site 13	Chicago	Illinois
United States	Braintree Research Site 1	Flowood	Mississippi
United States	Braintree Research Site 5	Gainesville	Florida
United States	Braintree Research Site 26	Indianapolis	Indiana
United States	Braintree Research Site 24	Jacksonville	Florida
United States	Braintree Research Site 20	Memphis	Tennessee
United States	Braintree Research Site 14	Milwaukee	Wisconsin
United States	Braintree Research Site 25	Minneapolis	Minnesota
United States	Braintree Research Site 27	Mobile	Alabama
United States	Braintree Research Site 19	New York	New York
United States	Braintree Research Site 28	New York	New York
United States	Braintree Research Site 17	Norfolk	Virginia
United States	Braintree Research Site 23	Orange	California
United States	Braintree Research Site 21	Orlando	Florida
United States	Braintree Research Site 3	Park Ridge	Illinois
United States	Braintree Research Site 6	Pittsburgh	Pennsylvania
United States	Braintree Research Site 34	Plano	Texas
United States	Braintree Research Site 4	Roanoke	Virginia
United States	Braintree Research Site 18	Rochester	Minnesota
United States	Braintree Research Site 22	Salt Lake City	Utah
United States	Braintree Research Site 16	San Francisco	California
United States	Braintree Research Site 11	Seattle	Washington
United States	Braintree Research Site 30	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and Percentage of Subjects With Successful Bowel Cleansing	Cleansing is rated by a blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent)	2 days