Trial Outcomes & Findings for A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults (NCT NCT02481947)
NCT ID: NCT02481947
Last Updated: 2020-07-27
Results Overview
The primary endpoint is based on the number of subjects who are weekly responders for at least 9 out of 12 weeks, with at least 3 of these weeks occurring in the last 4 weeks of treatment. A weekly responder is a subject who has ≥ 3 CSBMs and an increase from baseline of \> 1 CSBM in that week.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
459 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-07-27
Participant Flow
Participant milestones
| Measure |
BLI400 Laxative
BLI400 Laxative (21 gm BLI400 powder per day)
|
Lubiprostone
Lubiprostone (24 mcg capsule bid)
|
|---|---|---|
|
Overall Study
STARTED
|
230
|
229
|
|
Overall Study
COMPLETED
|
184
|
193
|
|
Overall Study
NOT COMPLETED
|
46
|
36
|
Reasons for withdrawal
| Measure |
BLI400 Laxative
BLI400 Laxative (21 gm BLI400 powder per day)
|
Lubiprostone
Lubiprostone (24 mcg capsule bid)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
24
|
10
|
|
Overall Study
Lost to Follow-up
|
11
|
5
|
|
Overall Study
Adverse Event
|
6
|
11
|
|
Overall Study
Physician Decision
|
4
|
5
|
|
Overall Study
Protocol Violation
|
1
|
5
|
Baseline Characteristics
A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults
Baseline characteristics by cohort
| Measure |
BLI400 Laxative
n=230 Participants
BLI400 Laxative
BLI400 Laxative: Oral laxative
|
Lubiprostone
n=229 Participants
Lubiprostone
Lubiprostone: Oral laxative
|
Total
n=459 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 13.6 • n=93 Participants
|
45.6 years
STANDARD_DEVIATION 14.6 • n=4 Participants
|
45.5 years
STANDARD_DEVIATION 14.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
187 Participants
n=93 Participants
|
179 Participants
n=4 Participants
|
366 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
93 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
95 Participants
n=93 Participants
|
98 Participants
n=4 Participants
|
193 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
135 Participants
n=93 Participants
|
131 Participants
n=4 Participants
|
266 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
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 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
|
63 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
131 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
156 Participants
n=93 Participants
|
146 Participants
n=4 Participants
|
302 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
|
2 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
230 participants
n=93 Participants
|
229 participants
n=4 Participants
|
459 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Per-protocol population
The primary endpoint is based on the number of subjects who are weekly responders for at least 9 out of 12 weeks, with at least 3 of these weeks occurring in the last 4 weeks of treatment. A weekly responder is a subject who has ≥ 3 CSBMs and an increase from baseline of \> 1 CSBM in that week.
Outcome measures
| Measure |
BLI400 Laxative
n=187 Participants
BLI400 Laxative (21 gm BLI400 powder)
|
Lubiprostone
n=199 Participants
Lubiprostone (24 mcg capsule bid)
|
|---|---|---|
|
Complete Spontaneous Bowel Movement (CSBM) Response
|
47 Participants
|
56 Participants
|
Adverse Events
BLI400 Laxative
Serious events: 2 serious events
Other events: 26 other events
Deaths: 1 deaths
Lubiprostone
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BLI400 Laxative
n=225 participants at risk
BLI400 Laxative (21 gm BLI400 powder)
|
Lubiprostone
n=229 participants at risk
Lubiprostone (24 mcg capsule bid)
|
|---|---|---|
|
Infections and infestations
Cellulitis of legs
|
0.44%
1/225 • Number of events 1 • 12 weeks
Results for mortality, serious adverse events and other adverse events are based on the FDA agreed upon Safety Population (BLI400 n=225, lubiprostone n=229).
|
0.00%
0/229 • 12 weeks
Results for mortality, serious adverse events and other adverse events are based on the FDA agreed upon Safety Population (BLI400 n=225, lubiprostone n=229).
|
|
General disorders
Death
|
0.44%
1/225 • Number of events 1 • 12 weeks
Results for mortality, serious adverse events and other adverse events are based on the FDA agreed upon Safety Population (BLI400 n=225, lubiprostone n=229).
|
0.00%
0/229 • 12 weeks
Results for mortality, serious adverse events and other adverse events are based on the FDA agreed upon Safety Population (BLI400 n=225, lubiprostone n=229).
|
|
Gastrointestinal disorders
stomach ulcer
|
0.00%
0/225 • 12 weeks
Results for mortality, serious adverse events and other adverse events are based on the FDA agreed upon Safety Population (BLI400 n=225, lubiprostone n=229).
|
0.44%
1/229 • Number of events 1 • 12 weeks
Results for mortality, serious adverse events and other adverse events are based on the FDA agreed upon Safety Population (BLI400 n=225, lubiprostone n=229).
|
Other adverse events
| Measure |
BLI400 Laxative
n=225 participants at risk
BLI400 Laxative (21 gm BLI400 powder)
|
Lubiprostone
n=229 participants at risk
Lubiprostone (24 mcg capsule bid)
|
|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
4.9%
11/225 • 12 weeks
Results for mortality, serious adverse events and other adverse events are based on the FDA agreed upon Safety Population (BLI400 n=225, lubiprostone n=229).
|
5.2%
12/229 • 12 weeks
Results for mortality, serious adverse events and other adverse events are based on the FDA agreed upon Safety Population (BLI400 n=225, lubiprostone n=229).
|
|
Gastrointestinal disorders
flatulence
|
7.6%
17/225 • 12 weeks
Results for mortality, serious adverse events and other adverse events are based on the FDA agreed upon Safety Population (BLI400 n=225, lubiprostone n=229).
|
1.3%
3/229 • 12 weeks
Results for mortality, serious adverse events and other adverse events are based on the FDA agreed upon Safety Population (BLI400 n=225, lubiprostone n=229).
|
Additional Information
Vice President, Clinical Affairs
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