Trial Outcomes & Findings for An Open-Label Preference Evaluation of BLI800 (NCT NCT04214301)
NCT ID: NCT04214301
Last Updated: 2023-10-23
Results Overview
Question: How easy or difficult was it to consume the study preparation?
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
2 days
Results posted on
2023-10-23
Participant Flow
Participant milestones
| Measure |
BLI800
BLI800
BLI800: BLI800 Bowel Preparation
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open-Label Preference Evaluation of BLI800
Baseline characteristics by cohort
| Measure |
BLI800
n=40 Participants
BLI800
BLI800: BLI800 Bowel Preparation
|
|---|---|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 12.6 • n=93 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2 daysQuestion: How easy or difficult was it to consume the study preparation?
Outcome measures
| Measure |
BLI800
n=38 Participants
BLI800
BLI800: BLI800 Bowel Preparation
|
|---|---|
|
Ease of Preparation Consumption
Very Difficult
|
3 Participants
|
|
Ease of Preparation Consumption
Difficult
|
5 Participants
|
|
Ease of Preparation Consumption
Tolerable
|
15 Participants
|
|
Ease of Preparation Consumption
Easy
|
7 Participants
|
|
Ease of Preparation Consumption
Very Easy
|
8 Participants
|
SECONDARY outcome
Timeframe: 2 daysQuestion: Were you able to consume the entire preparation as instructed?
Outcome measures
| Measure |
BLI800
n=38 Participants
BLI800
BLI800: BLI800 Bowel Preparation
|
|---|---|
|
Preparation Compliance
Yes
|
36 Participants
|
|
Preparation Compliance
No
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 daysOutcome measures
| Measure |
BLI800
n=38 Participants
BLI800
BLI800: BLI800 Bowel Preparation
|
|---|---|
|
Rating of Overall Experience
Excellent
|
9 Participants
|
|
Rating of Overall Experience
Good
|
20 Participants
|
|
Rating of Overall Experience
Fair
|
6 Participants
|
|
Rating of Overall Experience
Poor
|
3 Participants
|
|
Rating of Overall Experience
Bad
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Includes only those patients with a prior colonoscopy
How did this preparation experience compare to your prior experience?
Outcome measures
| Measure |
BLI800
n=22 Participants
BLI800
BLI800: BLI800 Bowel Preparation
|
|---|---|
|
Comparison to Prior Preparation
Worse
|
2 Participants
|
|
Comparison to Prior Preparation
Same
|
8 Participants
|
|
Comparison to Prior Preparation
Better
|
12 Participants
|
SECONDARY outcome
Timeframe: 2 daysWould you ask your doctor for this preparation again if you need another colonoscopy in the future?
Outcome measures
| Measure |
BLI800
n=38 Participants
BLI800
BLI800: BLI800 Bowel Preparation
|
|---|---|
|
Willingness to Repeat Preparation
Yes
|
30 Participants
|
|
Willingness to Repeat Preparation
No
|
8 Participants
|
SECONDARY outcome
Timeframe: 2 daysWould you refuse the same preparation again if it were to be prescribed to you in the future?
Outcome measures
| Measure |
BLI800
n=38 Participants
BLI800
BLI800: BLI800 Bowel Preparation
|
|---|---|
|
Refuse if Prescribed Again
Yes
|
5 Participants
|
|
Refuse if Prescribed Again
No
|
33 Participants
|
SECONDARY outcome
Timeframe: 2 daysOutcome measures
| Measure |
BLI800
n=38 Participants
BLI800
BLI800: BLI800 Bowel Preparation
|
|---|---|
|
Rating of Aftertaste
Very Pleasant
|
1 Participants
|
|
Rating of Aftertaste
Quite Pleasant
|
6 Participants
|
|
Rating of Aftertaste
Neither Pleasant Nor Unpleasant
|
15 Participants
|
|
Rating of Aftertaste
Quite Unpleasant
|
11 Participants
|
|
Rating of Aftertaste
Very Unpleasant
|
5 Participants
|
Adverse Events
BLI800
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BLI800
n=38 participants at risk
BLI800 (SUPREP Bowel Prep Kit)
|
|---|---|
|
Gastrointestinal disorders
Bloating
|
5.3%
2/38 • Number of events 2 • 2 days
|
|
Gastrointestinal disorders
Nausea
|
7.9%
3/38 • Number of events 3 • 2 days
|
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