Trial Outcomes & Findings for A Safety Study of 3 Different Bowel Cleansing Preparations (NCT NCT01501513)

Last Updated: 2024-01-17

Results Overview

Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

541 participants

Primary outcome timeframe

Day of colonoscopy

Results posted on

2024-01-17

Participant Flow

Participant milestones

Participant milestones
Measure	BLI800 Approved Preparation Regimen BLI800 approved preparation regimen BLI800 approved preparation regimen: solution for oral administration prior to colonoscopy	BLI800 Investigational Preparation Regimen BLI800 investigational preparation regimen BLI800 investigational preparation regimen: solution for oral administration prior to colonoscopy	PEG-3350 Based Bowel Preparation PEG-3350 based bowel preparation PEG-3350 based bowel preparation: solution for oral administration prior to colonoscopy
Overall Study STARTED	184	180	177
Overall Study COMPLETED	168	165	164
Overall Study NOT COMPLETED	16	15	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Safety Study of 3 Different Bowel Cleansing Preparations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BLI800 Approved Preparation Regimen n=184 Participants BLI800 approved preparation regimen BLI800 approved preparation regimen: solution for oral administration prior to colonoscopy	BLI800 Investigational Preparation Regimen n=180 Participants BLI800 investigational preparation regimen BLI800 investigational preparation regimen: solution for oral administration prior to colonoscopy	PEG-3350 Based Bowel Preparation n=177 Participants PEG-3350 based bowel preparation PEG-3350 based bowel preparation: solution for oral administration prior to colonoscopy	Total n=541 Participants Total of all reporting groups
Age, Continuous	56.8 years STANDARD_DEVIATION 11.5 • n=5 Participants	57.6 years STANDARD_DEVIATION 10.2 • n=7 Participants	56.6 years STANDARD_DEVIATION 10.9 • n=5 Participants	57.0 years STANDARD_DEVIATION 10.9 • n=4 Participants
Sex: Female, Male Female	101 Participants n=5 Participants	107 Participants n=7 Participants	111 Participants n=5 Participants	319 Participants n=4 Participants
Sex: Female, Male Male	83 Participants n=5 Participants	73 Participants n=7 Participants	66 Participants n=5 Participants	222 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	19 Participants n=7 Participants	18 Participants n=5 Participants	52 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	169 Participants n=5 Participants	161 Participants n=7 Participants	159 Participants n=5 Participants	489 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	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	14 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	24 Participants n=5 Participants	20 Participants n=7 Participants	31 Participants n=5 Participants	75 Participants n=4 Participants
Race (NIH/OMB) White	156 Participants n=5 Participants	156 Participants n=7 Participants	139 Participants n=5 Participants	451 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	184 Participants n=5 Participants	180 Participants n=7 Participants	177 Participants n=5 Participants	541 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day of colonoscopy

Population: The Primary Efficacy Outcome includes all patients that took a portion of study preparation, except those that did not undergo colonoscopy for a reason other than safety or efficacy (e.g., patient could not get a ride to their colonoscopy).

Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor).

Outcome measures

Outcome measures
Measure	BLI800 Approved Preparation Regimen n=183 Participants BLI800 approved preparation regimen BLI800 approved preparation regimen: solution for oral administration prior to colonoscopy	BLI800 Investigational Preparation Regimen n=179 Participants BLI800 investigational preparation regimen BLI800 investigational preparation regimen: solution for oral administration prior to colonoscopy	PEG-3350 Based Bowel Preparation n=177 Participants PEG-3350 based bowel preparation PEG-3350 based bowel preparation: solution for oral administration prior to colonoscopy
Percentage of Subjects With Successful Bowel Preparation	175 Participants	132 Participants	137 Participants

SECONDARY outcome

Timeframe: 2 days

Population: All subjects that took any portion of study preparation.

Count and Percentage of subjects with AEs through Day of Colonoscopy based on 3% threshold. Outcome measure time frame represents the day prior to colonoscopy (when preparation Dose 1 is taken) and the day of colonoscopy (when preparation Dose 2 is taken).

Outcome measures

Outcome measures
Measure	BLI800 Approved Preparation Regimen n=184 Participants BLI800 approved preparation regimen BLI800 approved preparation regimen: solution for oral administration prior to colonoscopy	BLI800 Investigational Preparation Regimen n=180 Participants BLI800 investigational preparation regimen BLI800 investigational preparation regimen: solution for oral administration prior to colonoscopy	PEG-3350 Based Bowel Preparation n=177 Participants PEG-3350 based bowel preparation PEG-3350 based bowel preparation: solution for oral administration prior to colonoscopy
Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy Abdominal distension	79 Participants	75 Participants	83 Participants
Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy Abdominal pain	65 Participants	56 Participants	50 Participants
Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy Nausea	77 Participants	50 Participants	54 Participants
Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy Vomiting	14 Participants	18 Participants	13 Participants
Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy Discomfort	105 Participants	92 Participants	90 Participants
Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy Anion gap increased	9 Participants	6 Participants	4 Participants
Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy Headache	6 Participants	7 Participants	11 Participants

SECONDARY outcome

Timeframe: 7 days

Population: All subjects who took a portion of study preparation.

Count and Percentage of subjects with AEs reported after colonoscopy through follow-up Day 7 based on 3% threshold. Outcome measure time frame represents the period following colonoscopy through follow-up Day 7 (7 days).

Outcome measures

Outcome measures
Measure	BLI800 Approved Preparation Regimen n=184 Participants BLI800 approved preparation regimen BLI800 approved preparation regimen: solution for oral administration prior to colonoscopy	BLI800 Investigational Preparation Regimen n=180 Participants BLI800 investigational preparation regimen BLI800 investigational preparation regimen: solution for oral administration prior to colonoscopy	PEG-3350 Based Bowel Preparation n=177 Participants PEG-3350 based bowel preparation PEG-3350 based bowel preparation: solution for oral administration prior to colonoscopy
Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7 Nausea	3 Participants	11 Participants	7 Participants
Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7 Abdominal distension	10 Participants	18 Participants	25 Participants
Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7 Abdominal pain	11 Participants	10 Participants	11 Participants

Adverse Events

BLI800 Approved Preparation Regimen

Serious events: 4 serious events

Other events: 145 other events

Deaths: 0 deaths

BLI800 Investigational Preparation Regimen

Serious events: 12 serious events

Other events: 129 other events

Deaths: 1 deaths

PEG-3350 Based Bowel Preparation

Serious events: 3 serious events

Other events: 127 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	BLI800 Approved Preparation Regimen n=184 participants at risk BLI800 approved preparation regimen BLI800 approved preparation regimen: solution for oral administration prior to colonoscopy	BLI800 Investigational Preparation Regimen n=180 participants at risk BLI800 investigational preparation regimen BLI800 investigational preparation regimen: solution for oral administration prior to colonoscopy	PEG-3350 Based Bowel Preparation n=177 participants at risk PEG-3350 based bowel preparation PEG-3350 based bowel preparation: solution for oral administration prior to colonoscopy
Gastrointestinal disorders Abdominal distension	45.7% 84/184 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.	49.4% 89/180 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.	53.1% 94/177 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.
Gastrointestinal disorders Abdominal pain	38.6% 71/184 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.	36.1% 65/180 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.	31.1% 55/177 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.
Gastrointestinal disorders Nausea	44.0% 81/184 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.	33.9% 61/180 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.	31.6% 56/177 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.
Gastrointestinal disorders Vomiting	8.7% 16/184 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.	12.8% 23/180 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.	9.0% 16/177 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.
General disorders Discomfort	58.7% 108/184 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.	55.6% 100/180 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.	53.7% 95/177 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.
Nervous system disorders Headache	3.8% 7/184 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.	4.4% 8/180 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.	6.8% 12/177 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.
Infections and infestations Urinary tract infection	5.4% 10/184 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.	2.8% 5/180 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.	2.8% 5/177 • 6 months The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.

Additional Information

Head of R&D, GI

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