Trial Outcomes & Findings for A Safety and Efficacy Study of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy (NCT NCT02819323)

NCT ID: NCT02819323

Last Updated: 2021-05-03

Results Overview

Cleansing is rated by a blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

91 participants

Primary outcome timeframe

2 days

Results posted on

2021-05-03

Participant Flow

Participant milestones

Participant milestones
Measure	BLI800 High Dose BLI800 bowel preparation (high dose) BLI800: BLI800 bowel preparation (6 oz)	BLI800 Low Dose BLI800 bowel preparation (low dose) BLI800: BLI800 bowel preparation (4.5 oz)	PEG-ELS PEG based bowel preparation PEG-ELS: polyethylene glycol based bowel preparation
Overall Study STARTED	31	28	32
Overall Study COMPLETED	26	26	31
Overall Study NOT COMPLETED	5	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BLI800 High Dose n=31 Participants BLI800 bowel preparation (high dose) BLI800: BLI800 bowel preparation (6 oz)	BLI800 Low Dose n=28 Participants BLI800 bowel preparation (low dose) BLI800: BLI800 bowel preparation (4.5 oz)	PEG-ELS n=32 Participants PEG based bowel preparation PEG-ELS: polyethylene glycol based bowel preparation	Total n=91 Participants Total of all reporting groups
Age, Continuous	14.6 years STANDARD_DEVIATION 1.2 • n=5 Participants	14.5 years STANDARD_DEVIATION 1.4 • n=7 Participants	14.4 years STANDARD_DEVIATION 1.4 • n=5 Participants	14.5 years STANDARD_DEVIATION 1.3 • n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	18 Participants n=7 Participants	15 Participants n=5 Participants	52 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants	39 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	26 Participants n=7 Participants	29 Participants n=5 Participants	82 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	24 Participants n=7 Participants	20 Participants n=5 Participants	71 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment United States	31 participants n=5 Participants	28 participants n=7 Participants	32 participants n=5 Participants	91 participants n=4 Participants

PRIMARY outcome

Timeframe: 2 days

Population: Efficacy population

Cleansing is rated by a blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent)

Outcome measures

Outcome measures
Measure	BLI800 High Dose n=31 Participants BLI800 bowel preparation (high dose) BLI800: BLI800 bowel preparation (6 oz)	BLI800 Low Dose n=27 Participants BLI800 bowel preparation (low dose) BLI800: BLI800 bowel preparation (4.5 oz)	PEG-ELS n=32 Participants PEG based bowel preparation PEG-ELS: polyethylene glycol based bowel preparation
Number and Percentage of Subjects With Successful Bowel Cleansing	25 Participants	22 Participants	19 Participants

Adverse Events

BLI800 High Dose

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

BLI800 Low Dose

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

PEG-ELS

Serious events: 1 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BLI800 High Dose n=31 participants at risk BLI800 bowel preparation (high dose) BLI800: BLI800 bowel preparation (6 oz)	BLI800 Low Dose n=28 participants at risk BLI800 bowel preparation (low dose) BLI800: BLI800 bowel preparation (4.5 oz)	PEG-ELS n=32 participants at risk PEG based bowel preparation PEG-ELS: polyethylene glycol based bowel preparation
Injury, poisoning and procedural complications alcohol intoxication	0.00% 0/31 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	0.00% 0/28 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	3.1% 1/32 • Number of events 1 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.
Injury, poisoning and procedural complications Accidental Tylenol Ingestion	0.00% 0/31 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	0.00% 0/28 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	3.1% 1/32 • Number of events 1 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.

Other adverse events

Additional Information

Head of R&D, Gastroenterology

Braintree Laboratories, Inc.

Phone: 781-843-2202

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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
Publication restrictions are in place

Restriction type: OTHER

Measure	BLI800 High Dose n=31 participants at risk BLI800 bowel preparation (high dose) BLI800: BLI800 bowel preparation (6 oz)	BLI800 Low Dose n=28 participants at risk BLI800 bowel preparation (low dose) BLI800: BLI800 bowel preparation (4.5 oz)	PEG-ELS n=32 participants at risk PEG based bowel preparation PEG-ELS: polyethylene glycol based bowel preparation
Gastrointestinal disorders Abdominal distension	64.5% 20/31 • Number of events 20 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	32.1% 9/28 • Number of events 9 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	53.1% 17/32 • Number of events 17 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.
Gastrointestinal disorders Abdominal pain upper	54.8% 17/31 • Number of events 17 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	57.1% 16/28 • Number of events 16 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	62.5% 20/32 • Number of events 20 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.
Gastrointestinal disorders Abdominal pain	16.1% 5/31 • Number of events 5 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	7.1% 2/28 • Number of events 2 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	0.00% 0/32 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.
Gastrointestinal disorders Nausea	74.2% 23/31 • Number of events 23 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	57.1% 16/28 • Number of events 16 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	84.4% 27/32 • Number of events 27 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.
Gastrointestinal disorders Vomiting	19.4% 6/31 • Number of events 6 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	28.6% 8/28 • Number of events 8 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	37.5% 12/32 • Number of events 12 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.
Nervous system disorders Headache	12.9% 4/31 • Number of events 4 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	3.6% 1/28 • Number of events 1 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	0.00% 0/32 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.
Gastrointestinal disorders Anorectal discomfort	6.5% 2/31 • Number of events 2 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	0.00% 0/28 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	0.00% 0/32 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.
Gastrointestinal disorders Retching	6.5% 2/31 • Number of events 2 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	0.00% 0/28 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	0.00% 0/32 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.
Investigations Anion gap increased	9.7% 3/31 • Number of events 3 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	10.7% 3/28 • Number of events 3 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	6.2% 2/32 • Number of events 2 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.
Investigations Bacterial test positive	6.5% 2/31 • Number of events 2 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	7.1% 2/28 • Number of events 2 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	0.00% 0/32 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.
Investigations Blood bicarbonate decreased	6.5% 2/31 • Number of events 2 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	0.00% 0/28 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	0.00% 0/32 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.
Investigations Urine leukocyte esterase positive	6.5% 2/31 • Number of events 2 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	3.6% 1/28 • Number of events 1 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	3.1% 1/32 • Number of events 1 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.
Investigations White blood cells urine positive	0.00% 0/31 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	7.1% 2/28 • Number of events 2 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	3.1% 1/32 • Number of events 1 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.
Musculoskeletal and connective tissue disorders Back pain	6.5% 2/31 • Number of events 2 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	0.00% 0/28 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	0.00% 0/32 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	9.7% 3/31 • Number of events 3 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	0.00% 0/28 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	0.00% 0/32 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.
Investigations Anion gap decreased	0.00% 0/31 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	0.00% 0/28 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.	6.2% 2/32 • Number of events 2 • 30 days Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.