Trial Outcomes & Findings for BLI800-480: A Safety and Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects (NCT NCT01786629)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

338 participants

Primary outcome timeframe

Day of colonoscopy

Results posted on

2014-08-08

Participant Flow

Participant milestones

Participant milestones
Measure	SUPREP Bowel Prep Kit SUPREP Bowel Prep Kit SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy	FDA Approved Bowel Preparation FDA approved bowel preparation containing electrolytes FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy
Overall Study STARTED	169	169
Overall Study COMPLETED	169	164
Overall Study NOT COMPLETED	0	5

Reasons for withdrawal

Reasons for withdrawal
Measure	SUPREP Bowel Prep Kit SUPREP Bowel Prep Kit SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy	FDA Approved Bowel Preparation FDA approved bowel preparation containing electrolytes FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy
Overall Study Lack of Efficacy	0	4
Overall Study Adverse Event	0	1

Baseline Characteristics

BLI800-480: A Safety and Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SUPREP Bowel Prep Kit n=169 Participants SUPREP Bowel Prep Kit SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy	FDA Approved Bowel Preparation n=169 Participants FDA approved bowel preparation containing electrolytes FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy	Total n=338 Participants Total of all reporting groups
Region of Enrollment United States	169 participants n=5 Participants	169 participants n=7 Participants	338 participants n=5 Participants
Weight	188 lbs STANDARD_DEVIATION 39 • n=5 Participants	192 lbs STANDARD_DEVIATION 49 • n=7 Participants	190 lbs STANDARD_DEVIATION 45 • n=5 Participants
Age, Continuous	57.9 years STANDARD_DEVIATION 10.4 • n=5 Participants	57.8 years STANDARD_DEVIATION 9.6 • n=7 Participants	57.8 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	93 Participants n=7 Participants	187 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants	76 Participants n=7 Participants	151 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day of colonoscopy

Population: The analysis population contains subjects that consumed any portion of their bowel preparation. Subject who discontinued from the study for reasons other safety of efficacy are not included (e.g. insurance issues).

Outcome measures

Outcome measures
Measure	SUPREP Bowel Prep Kit n=169 Participants SUPREP Bowel Prep Kit SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy	FDA Approved Bowel Preparation n=169 Participants FDA approved bowel preparation containing electrolytes FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy
Percentage of Subjects With a Successful Preparation (Cleaning Rated as "Good" or "Excellent")	95 percentage of subjects	86 percentage of subjects

Adverse Events

SUPREP Bowel Prep Kit

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

FDA Approved Bowel Preparation

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SUPREP Bowel Prep Kit n=169 participants at risk SUPREP Bowel Prep Kit SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy	FDA Approved Bowel Preparation n=169 participants at risk FDA approved bowel preparation containing electrolytes FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy
Hepatobiliary disorders cholelithiasis	0.00% 0/169 • Treatment emergent adverse events were collected for Preparation Day 1 and Day 2 (Day of Colonoscopy). Serious adverse events were collected for a period of 30 days. Adverse events for stomach cramping, stomach bloating and nausea were documented only if the symptom required an intervention or resulted in discontinuation of the bowel preparation.	0.59% 1/169 • Number of events 1 • Treatment emergent adverse events were collected for Preparation Day 1 and Day 2 (Day of Colonoscopy). Serious adverse events were collected for a period of 30 days. Adverse events for stomach cramping, stomach bloating and nausea were documented only if the symptom required an intervention or resulted in discontinuation of the bowel preparation.
Hepatobiliary disorders cholecystitis	0.00% 0/169 • Treatment emergent adverse events were collected for Preparation Day 1 and Day 2 (Day of Colonoscopy). Serious adverse events were collected for a period of 30 days. Adverse events for stomach cramping, stomach bloating and nausea were documented only if the symptom required an intervention or resulted in discontinuation of the bowel preparation.	0.59% 1/169 • Number of events 1 • Treatment emergent adverse events were collected for Preparation Day 1 and Day 2 (Day of Colonoscopy). Serious adverse events were collected for a period of 30 days. Adverse events for stomach cramping, stomach bloating and nausea were documented only if the symptom required an intervention or resulted in discontinuation of the bowel preparation.
Hepatobiliary disorders bile duct stone	0.00% 0/169 • Treatment emergent adverse events were collected for Preparation Day 1 and Day 2 (Day of Colonoscopy). Serious adverse events were collected for a period of 30 days. Adverse events for stomach cramping, stomach bloating and nausea were documented only if the symptom required an intervention or resulted in discontinuation of the bowel preparation.	0.59% 1/169 • Number of events 1 • Treatment emergent adverse events were collected for Preparation Day 1 and Day 2 (Day of Colonoscopy). Serious adverse events were collected for a period of 30 days. Adverse events for stomach cramping, stomach bloating and nausea were documented only if the symptom required an intervention or resulted in discontinuation of the bowel preparation.
General disorders chest pain	0.00% 0/169 • Treatment emergent adverse events were collected for Preparation Day 1 and Day 2 (Day of Colonoscopy). Serious adverse events were collected for a period of 30 days. Adverse events for stomach cramping, stomach bloating and nausea were documented only if the symptom required an intervention or resulted in discontinuation of the bowel preparation.	0.59% 1/169 • Number of events 1 • Treatment emergent adverse events were collected for Preparation Day 1 and Day 2 (Day of Colonoscopy). Serious adverse events were collected for a period of 30 days. Adverse events for stomach cramping, stomach bloating and nausea were documented only if the symptom required an intervention or resulted in discontinuation of the bowel preparation.

Other adverse events

Adverse event data not reported

Additional Information

John McGowan, Director Clinical Research

Braintree Laboratories, Inc.

Phone: 781-843-2202

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 360 days from the time submitted to the sponsor for review. The sponsor cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER