Trial Outcomes & Findings for Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy (NCT NCT02189850)
NCT ID: NCT02189850
Last Updated: 2021-03-15
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
2 days
Results posted on
2021-03-15
Participant Flow
Participant milestones
| Measure |
BLI800 - Dose 1
BLI800 oral solution
BLI800 - Dose 1: BLI800 oral solution (6 oz)
|
BLI800 - Dose 2
BLI800 oral solution
BLI800 - Dose 2: BLI800 oral solution (4.5 oz)
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
13
|
|
Overall Study
COMPLETED
|
14
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
Baseline characteristics by cohort
| Measure |
BLI800 - Dose 1
n=16 Participants
BLI800 oral solution
BLI800 - Dose 1: BLI800 oral solution (6 oz)
|
BLI800 - Dose 2
n=13 Participants
BLI800 oral solution
BLI800 - Dose 2: BLI800 oral solution (4.5 oz)
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.2 years
STANDARD_DEVIATION 1.2 • n=93 Participants
|
15.8 years
STANDARD_DEVIATION 1.4 • n=4 Participants
|
15.5 years
STANDARD_DEVIATION 1.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=93 Participants
|
13 participants
n=4 Participants
|
29 participants
n=27 Participants
|
|
Puburtal Staging
I
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Puburtal Staging
II
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Puburtal Staging
III
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Puburtal Staging
IV
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Puburtal Staging
V
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 daysPopulation: Efficacy population
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
Outcome measures
| Measure |
BLI800 - Dose 1
n=16 Participants
BLI800 oral solution
BLI800 - Dose 1: BLI800 oral solution (6 oz)
|
BLI800 - Dose 2
n=12 Participants
BLI800 oral solution
BLI800 - Dose 2: BLI800 oral solution (4.5 oz)
|
|---|---|---|
|
% of Subjects With Successful Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent)
|
13 Participants
|
10 Participants
|
Adverse Events
BLI800 - Dose 1
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
BLI800 - Dose 2
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BLI800 - Dose 1
n=16 participants at risk
BLI800 oral solution
BLI800 - Dose 1: BLI800 oral solution (6 oz)
|
BLI800 - Dose 2
n=13 participants at risk
BLI800 oral solution
BLI800 - Dose 2: BLI800 oral solution (4.5 oz)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
31.2%
5/16 • Number of events 5
|
61.5%
8/13 • Number of events 8
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16
|
23.1%
3/13 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
31.2%
5/16 • Number of events 5
|
30.8%
4/13 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Anal fissure
|
6.2%
1/16 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
6.2%
1/16 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
50.0%
8/16 • Number of events 8
|
46.2%
6/13 • Number of events 6
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Number of events 2
|
15.4%
2/13 • Number of events 2
|
|
General disorders
Chills
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Injection site pain
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Pyrexia
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
Investigations
Bacterial test
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
Investigations
Blood bilirubin increased
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
Investigations
Blood creatine phosphokinase increased
|
12.5%
2/16 • Number of events 2
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Liver function test abnormal
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
Investigations
Protein urine present
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
Investigations
Urinary casts
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/16
|
23.1%
3/13 • Number of events 3
|
|
Nervous system disorders
Syncope
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Helicobacter infection
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
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