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

• Sponsor: Braintree Laboratories (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02189850
• Collaborator: (none)
• Enrollment: 29
• Locations: 5
• Arms: 2
• Duration (Months): 7
• Patients Per Site: 5.8
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The purpose o this study is to evaluate the safety, tolerance and efficacy of BLI800 as a bowel preparation prior to colonoscopy in pediatric patients.

Condition or Disease	Intervention/Treatment	Phase
Colonoscopy	Drug: BLI800 - Dose 1; Drug: BLI800 - Dose 2	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BLI800 - Dose 1 BLI800 oral solution	Drug: BLI800 - Dose 1; BLI800 oral solution; Other Names: BLI800
Experimental: BLI800 - Dose 2 BLI800 oral solution	Drug: BLI800 - Dose 2; BLI800 oral solution; Other Names: BLI800

Outcome Measures

Primary Outcome Measures

1. % of Subjects With Successful Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent) [2 days]

   Successful Preparation, defined as a colonoscopy rated as Excellent or Good by the blinded endoscopist. Poor: Large amounts of fecal residue, additional bowel preparation required; Fair: Enough feces even after washing and suctioning to prevent clear visualization of the entire colonic mucosa; Good: Feces and fluid requiring washing and suctioning, but still achieves clear visualization of the entire colonic mucosa; Excellent: No more than small bits of feces/fluid which can be suctioned easily; achieves clear visualization of the entire colonic mucosa

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• Male or female between the ages of 12 to 17

• Weight more than 40kg

• Undergoing colonoscopy for routinely accepted indications

• 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.

• Negative pregnancy test at screening, if applicable

• In the Investigator's judgment, caregiver is mentally competent to provide informed consent for their child to participate in the study.

Exclusion Criteria:

• Subjects with known or suspected ileus, impaction, severe ulcerative colitis, acute peritonitis, gastrointestinal obstruction, gastric retention (gastroparesis), bowel perforation, toxic colitis or megacolon.

• Subjects who had previous significant gastrointestinal surgeries.

• Subjects with increased risk of bowel perforation, including connective tissue disorders, toxic dilation of the bowel or recent bowel surgery.

• Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results

• Subjects with bleeding disorders and/or impaired platelet function, or neutropenia.

• Subjects with a prior history of renal, liver or cardiac insufficiency

• Subjects required to take any other oral medication within 3 hours of dosing until completion of both doses.

• Subjects with impaired consciousness that predisposes them to pulmonary aspiration.

• Subjects with tendency for nausea and/or vomiting, or that have known swallowing disorders.

• Subjects for whom intake of substances is likely to affect gastrointestinal motility or urinary flow rate.

• Subjects undergoing colonoscopy for foreign body removal and/or decompression.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Children's Hospital Research Institute	Little Rock	Arkansas	United States
2	Children's Center for Digestive Health Care	Atlanta	Georgia	United States
3	Delta Research Partners	Bastrop	Louisiana	United States
4	Gastrointestinal Associates	Jackson	Mississippi	United States
5	University of Buffalo Pediatric Associates	Buffalo	New York	United States

Sponsors and Collaborators

• Braintree Laboratories

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Braintree Laboratories
• ClinicalTrials.gov Identifier: NCT02189850
• Other Study ID Numbers: BLI800-501
• First Posted: Jul 15, 2014
• Last Update Posted: Mar 15, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Braintree Laboratories: colonoscopy; pediatric

Study Results

Participant Flow

Arm/Group Title	BLI800 - Dose 1	BLI800 - Dose 2
Arm/Group Description	BLI800 oral solution BLI800 - Dose 1: BLI800 oral solution (6 oz)	BLI800 oral solution BLI800 - Dose 2: BLI800 oral solution (4.5 oz)
Period Title: Overall Study
STARTED	16	13
COMPLETED	14	11
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	BLI800 - Dose 1	BLI800 - Dose 2	Total
Arm/Group Description	BLI800 oral solution BLI800 - Dose 1: BLI800 oral solution (6 oz)	BLI800 oral solution BLI800 - Dose 2: BLI800 oral solution (4.5 oz)	Total of all reporting groups
Overall Participants	16	13	29
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15.2 (1.2)	15.8 (1.4)	15.5 (1.3)
Sex: Female, Male (Count of Participants)
Female	7 43.8%	8 61.5%	15 51.7%
Male	9 56.3%	5 38.5%	14 48.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 6.3%	0 0%	1 3.4%
Not Hispanic or Latino	15 93.8%	13 100%	28 96.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 25%	2 15.4%	6 20.7%
White	12 75%	10 76.9%	22 75.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 7.7%	1 3.4%
Region of Enrollment (participants) [Number]
United States	16 100%	13 100%	29 100%
Puburtal Staging (Count of Participants)
I	0 0%	0 0%	0 0%
II	0 0%	1 7.7%	1 3.4%
III	1 6.3%	0 0%	1 3.4%
IV	3 18.8%	1 7.7%	4 13.8%
V	12 75%	11 84.6%	23 79.3%

Outcome Measures

1. Primary Outcome

Title	% of Subjects With Successful Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent)
Description	Successful Preparation, defined as a colonoscopy rated as Excellent or Good by the blinded endoscopist. Poor: Large amounts of fecal residue, additional bowel preparation required; Fair: Enough feces even after washing and suctioning to prevent clear visualization of the entire colonic mucosa; Good: Feces and fluid requiring washing and suctioning, but still achieves clear visualization of the entire colonic mucosa; Excellent: No more than small bits of feces/fluid which can be suctioned easily; achieves clear visualization of the entire colonic mucosa
Time Frame	2 days

Outcome Measure Data

Analysis Population Description

Efficacy population

Arm/Group Title	BLI800 - Dose 1	BLI800 - Dose 2
Arm/Group Description	BLI800 oral solution BLI800 - Dose 1: BLI800 oral solution (6 oz)	BLI800 oral solution BLI800 - Dose 2: BLI800 oral solution (4.5 oz)
Measure Participants	16	12
Count of Participants [Participants]	13 81.3%	10 76.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BLI800 - Dose 1, BLI800 - Dose 2
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.923
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Adverse Events

Arm/Group Title	BLI800 - Dose 1		BLI800 - Dose 2
Arm/Group Description	BLI800 oral solution BLI800 - Dose 1: BLI800 oral solution (6 oz)		BLI800 oral solution BLI800 - Dose 2: BLI800 oral solution (4.5 oz)
All Cause Mortality
	BLI800 - Dose 1		BLI800 - Dose 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/13 (0%)
Serious Adverse Events
	BLI800 - Dose 1		BLI800 - Dose 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	BLI800 - Dose 1		BLI800 - Dose 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/16 (81.3%)		12/13 (92.3%)
Gastrointestinal disorders
Abdominal discomfort	0/16 (0%)	0	1/13 (7.7%)	1
Abdominal distension	5/16 (31.3%)	5	8/13 (61.5%)	8
Abdominal pain	0/16 (0%)	0	3/13 (23.1%)	3
Abdominal pain upper	5/16 (31.3%)	5	4/13 (30.8%)	4
Abdominal tenderness	0/16 (0%)	0	1/13 (7.7%)	1
Anal fissure	1/16 (6.3%)	1	1/13 (7.7%)	1
Anorectal discomfort	0/16 (0%)	0	1/13 (7.7%)	1
Diarrhea	0/16 (0%)	0	1/13 (7.7%)	1
Eructation	0/16 (0%)	0	1/13 (7.7%)	1
Gastric ulcer	0/16 (0%)	0	1/13 (7.7%)	1
Gastritis	1/16 (6.3%)	1	1/13 (7.7%)	1
Nausea	8/16 (50%)	8	6/13 (46.2%)	6
Rectal hemorrhage	0/16 (0%)	0	1/13 (7.7%)	1
Vomiting	2/16 (12.5%)	2	2/13 (15.4%)	2
General disorders
Chills	0/16 (0%)	0	1/13 (7.7%)	1
Injection site pain	0/16 (0%)	0	1/13 (7.7%)	1
Pyrexia	1/16 (6.3%)	1	0/13 (0%)	0
Infections and infestations
Helicobacter infection	1/16 (6.3%)	1	0/13 (0%)	0
Investigations
Bacterial test	1/16 (6.3%)	1	0/13 (0%)	0
Blood bilirubin increased	1/16 (6.3%)	1	0/13 (0%)	0
Blood creatine phosphokinase increased	2/16 (12.5%)	2	1/13 (7.7%)	1
Liver function test abnormal	1/16 (6.3%)	1	0/13 (0%)	0
Protein urine present	1/16 (6.3%)	1	0/13 (0%)	0
Urinary casts	1/16 (6.3%)	1	0/13 (0%)	0
Metabolism and nutrition disorders
Metabolic acidosis	0/16 (0%)	0	1/13 (7.7%)	1
Nervous system disorders
Headache	0/16 (0%)	0	3/13 (23.1%)	3
Syncope	0/16 (0%)	0	1/13 (7.7%)	1
Psychiatric disorders
Anxiety	0/16 (0%)	0	1/13 (7.7%)	1
Reproductive system and breast disorders
Dysmenorrhea	0/16 (0%)	0	1/13 (7.7%)	1
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	0/16 (0%)	0	1/13 (7.7%)	1
Skin and subcutaneous tissue disorders
Eczema	0/16 (0%)	0	1/13 (7.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The sole disclosure restriction which sponsor imposes on the PI is a sixty (60) day limited restriction in order to the protect potentially proprietary information which may be patentable