Trial Outcomes & Findings for BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults (NCT NCT02819297)
NCT ID: NCT02819297
Last Updated: 2020-07-27
Results Overview
The primary endpoint is the proportion 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
1020 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-07-27
Participant Flow
1020 subjects were consented and entered into a two-week run-in period to confirm constipation status (subjects were required to average \< 3 complete spontaneous bowel movements per week). Following the run-in period, 603 subjects qualified for randomization.
Participant milestones
| Measure |
BLI400 Laxative
BLI400 Laxative (21 gm of BLI400 powder)
|
Placebo
BLI400 placebo (equivalent amount of placebo powder)
|
|---|---|---|
|
Overall Study
STARTED
|
299
|
304
|
|
Overall Study
COMPLETED
|
239
|
252
|
|
Overall Study
NOT COMPLETED
|
60
|
52
|
Reasons for withdrawal
| Measure |
BLI400 Laxative
BLI400 Laxative (21 gm of BLI400 powder)
|
Placebo
BLI400 placebo (equivalent amount of placebo powder)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
25
|
13
|
|
Overall Study
Lost to Follow-up
|
12
|
14
|
|
Overall Study
Adverse Event
|
12
|
10
|
|
Overall Study
Physician Decision
|
5
|
5
|
|
Overall Study
Lack of Efficacy
|
5
|
8
|
|
Overall Study
Protocol Violation
|
1
|
2
|
Baseline Characteristics
BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults
Baseline characteristics by cohort
| Measure |
BLI400 Laxative
n=299 Participants
BLI400 Laxative (21 gm BLI400 powder)
|
Placebo
n=304 Participants
BLI400 placebo (equivalent amount of placebo powder)
|
Total
n=603 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
51.0 years
STANDARD_DEVIATION 15.9 • n=7 Participants
|
51.7 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
221 Participants
n=5 Participants
|
239 Participants
n=7 Participants
|
460 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
119 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
180 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
370 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
88 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
187 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
365 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
299 participants
n=5 Participants
|
304 participants
n=7 Participants
|
603 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: modified ITT population - excludes subjects with significant protocol violations
The primary endpoint is the proportion 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=294 Participants
BLI400 Laxative (21 gm BLI400 powder)
|
Placebo
n=302 Participants
BLI400 placebo (equivalent amount of placebo powder)
|
|---|---|---|
|
Treatment Response
|
77 Participants
|
39 Participants
|
Adverse Events
BLI400 Laxative
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Placebo
Serious events: 8 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BLI400 Laxative
n=299 participants at risk
BLI400 Laxative (21 gm BLI400 powder)
|
Placebo
n=304 participants at risk
BLI400 placebo (equivalent amount of placebo powder)
|
|---|---|---|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/299 • 6 months
|
0.33%
1/304 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/299 • 6 months
|
0.33%
1/304 • Number of events 1 • 6 months
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/299 • 6 months
|
0.33%
1/304 • Number of events 1 • 6 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/299 • 6 months
|
0.33%
1/304 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/299 • 6 months
|
0.33%
1/304 • Number of events 1 • 6 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.33%
1/299 • Number of events 1 • 6 months
|
0.33%
1/304 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/299 • 6 months
|
0.33%
1/304 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Bile duct stone
|
0.33%
1/299 • Number of events 1 • 6 months
|
0.00%
0/304 • 6 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/299 • 6 months
|
0.33%
1/304 • Number of events 1 • 6 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/299 • 6 months
|
0.33%
1/304 • Number of events 1 • 6 months
|
|
Investigations
Blood pressure increased
|
0.33%
1/299 • Number of events 1 • 6 months
|
0.00%
0/304 • 6 months
|
Other adverse events
| Measure |
BLI400 Laxative
n=299 participants at risk
BLI400 Laxative (21 gm BLI400 powder)
|
Placebo
n=304 participants at risk
BLI400 placebo (equivalent amount of placebo powder)
|
|---|---|---|
|
Gastrointestinal disorders
Flatulence
|
8.0%
24/299 • Number of events 24 • 6 months
|
2.6%
8/304 • Number of events 8 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
6.7%
20/299 • Number of events 20 • 6 months
|
8.6%
26/304 • Number of events 26 • 6 months
|
Additional Information
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