Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02189850
Recruitment Status : Completed
First Posted : July 15, 2014
Results First Posted : March 15, 2021
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colonoscopy
Interventions Drug: BLI800 - Dose 1
Drug: BLI800 - Dose 2
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BLI800 - Dose 1 BLI800 - Dose 2
Hide 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 [1] 16 13
Completed 14 11
Not Completed 2 2
[1]
Safety population - all subjects that took preparation.
Arm/Group Title BLI800 - Dose 1 BLI800 - Dose 2 Total
Hide 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 Number of Baseline Participants 16 13 29
Hide Baseline Analysis Population Description
Safety population - all subjects that took preparation.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 13 participants 29 participants
15.2  (1.2) 15.8  (1.4) 15.5  (1.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 29 participants
Female
7
  43.8%
8
  61.5%
15
  51.7%
Male
9
  56.3%
5
  38.5%
14
  48.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 29 participants
Hispanic or Latino
1
   6.3%
0
   0.0%
1
   3.4%
Not Hispanic or Latino
15
  93.8%
13
 100.0%
28
  96.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 29 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  25.0%
2
  15.4%
6
  20.7%
White
12
  75.0%
10
  76.9%
22
  75.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   7.7%
1
   3.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 13 participants 29 participants
16 13 29
Puburtal Staging   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 29 participants
I
0
   0.0%
0
   0.0%
0
   0.0%
II
0
   0.0%
1
   7.7%
1
   3.4%
III
1
   6.3%
0
   0.0%
1
   3.4%
IV
3
  18.8%
1
   7.7%
4
  13.8%
V
12
  75.0%
11
  84.6%
23
  79.3%
[1]
Measure Description: Pubertal Tanner Staging from I (prepubertal) to V (adult genitalia)
1.Primary Outcome
Title % of Subjects With Successful Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population
Arm/Group Title BLI800 - Dose 1 BLI800 - Dose 2
Hide 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)

Overall Number of Participants Analyzed 16 12
Measure Type: Count of Participants
Unit of Measure: Participants
13
  81.3%
10
  83.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BLI800 - Dose 1, BLI800 - Dose 2
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.923
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BLI800 - Dose 1 BLI800 - Dose 2
Hide 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 (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/13 (0.00%)    
Hide Serious Adverse Events
BLI800 - Dose 1 BLI800 - Dose 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/13 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BLI800 - Dose 1 BLI800 - Dose 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/16 (81.25%)      12/13 (92.31%)    
Gastrointestinal disorders     
Abdominal discomfort *  0/16 (0.00%)  0 1/13 (7.69%)  1
Abdominal distension   5/16 (31.25%)  5 8/13 (61.54%)  8
Abdominal pain *  0/16 (0.00%)  0 3/13 (23.08%)  3
Abdominal pain upper   5/16 (31.25%)  5 4/13 (30.77%)  4
Abdominal tenderness *  0/16 (0.00%)  0 1/13 (7.69%)  1
Anal fissure *  1/16 (6.25%)  1 1/13 (7.69%)  1
Anorectal discomfort *  0/16 (0.00%)  0 1/13 (7.69%)  1
Diarrhea *  0/16 (0.00%)  0 1/13 (7.69%)  1
Eructation *  0/16 (0.00%)  0 1/13 (7.69%)  1
Gastric ulcer *  0/16 (0.00%)  0 1/13 (7.69%)  1
Gastritis *  1/16 (6.25%)  1 1/13 (7.69%)  1
Nausea   8/16 (50.00%)  8 6/13 (46.15%)  6
Rectal hemorrhage *  0/16 (0.00%)  0 1/13 (7.69%)  1
Vomiting   2/16 (12.50%)  2 2/13 (15.38%)  2
General disorders     
Chills *  0/16 (0.00%)  0 1/13 (7.69%)  1
Injection site pain *  0/16 (0.00%)  0 1/13 (7.69%)  1
Pyrexia *  1/16 (6.25%)  1 0/13 (0.00%)  0
Infections and infestations     
Helicobacter infection *  1/16 (6.25%)  1 0/13 (0.00%)  0
Investigations     
Bacterial test *  1/16 (6.25%)  1 0/13 (0.00%)  0
Blood bilirubin increased *  1/16 (6.25%)  1 0/13 (0.00%)  0
Blood creatine phosphokinase increased *  2/16 (12.50%)  2 1/13 (7.69%)  1
Liver function test abnormal *  1/16 (6.25%)  1 0/13 (0.00%)  0
Protein urine present *  1/16 (6.25%)  1 0/13 (0.00%)  0
Urinary casts *  1/16 (6.25%)  1 0/13 (0.00%)  0
Metabolism and nutrition disorders     
Metabolic acidosis *  0/16 (0.00%)  0 1/13 (7.69%)  1
Nervous system disorders     
Headache *  0/16 (0.00%)  0 3/13 (23.08%)  3
Syncope *  0/16 (0.00%)  0 1/13 (7.69%)  1
Psychiatric disorders     
Anxiety *  0/16 (0.00%)  0 1/13 (7.69%)  1
Reproductive system and breast disorders     
Dysmenorrhea *  0/16 (0.00%)  0 1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain *  0/16 (0.00%)  0 1/13 (7.69%)  1
Skin and subcutaneous tissue disorders     
Eczema *  0/16 (0.00%)  0 1/13 (7.69%)  1
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head of R&D, Gastroenterology
Organization: Braintree Laboratories, Inc.
Phone: 781-843-2202
EMail: studydirector@sebelapharma.com
Layout table for additonal information
Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT02189850    
Other Study ID Numbers: BLI800-501
First Submitted: July 10, 2014
First Posted: July 15, 2014
Results First Submitted: February 2, 2021
Results First Posted: March 15, 2021
Last Update Posted: March 15, 2021