Trial Outcomes & Findings for An Open Label Study of Chronic Use of BLI400 Laxative in Constipated Adults (NCT NCT02819310)

Last Updated: 2020-07-09

Results Overview

% of subjects experiencing a treatment emergent adverse event during the 12 month treatment period

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

330 participants

Primary outcome timeframe

12 months

Results posted on

2020-07-09

Participant milestones
Measure	BLI400 Laxative BLI400 Laxative BLI400 Laxative: oral laxative
Overall Study STARTED	330
Overall Study COMPLETED	221
Overall Study NOT COMPLETED	109

Reasons for withdrawal
Measure	BLI400 Laxative BLI400 Laxative BLI400 Laxative: oral laxative
Overall Study Withdrawal by Subject	37
Overall Study Lost to Follow-up	16
Overall Study Adverse Event	13
Overall Study Lack of Efficacy	5
Overall Study Physician Decision	8
Overall Study Protocol Violation	30

An Open Label Study of Chronic Use of BLI400 Laxative in Constipated Adults

Baseline characteristics by cohort
Measure	BLI400 Laxative n=305 Participants BLI400 Laxative BLI400 Laxative: oral laxative
Age, Continuous	54.5 years STANDARD_DEVIATION 16.0 • n=5 Participants
Sex: Female, Male Female	223 Participants n=5 Participants
Sex: Female, Male Male	82 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	133 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	172 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	91 Participants n=5 Participants
Race (NIH/OMB) White	205 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	305 participants n=5 Participants

Timeframe: 12 months

Population: FDA agreed upon Safety Population

% of subjects experiencing a treatment emergent adverse event during the 12 month treatment period

Outcome measures
Measure	BLI400 Laxative n=305 Participants BLI400 Laxative BLI400 Laxative: oral laxative
% of Subjects With Treatment Emergent Adverse Events	108 Participants

Serious events: 2 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events
Measure	BLI400 Laxative n=305 participants at risk BLI400 Laxative BLI400 Laxative: oral laxative
Hepatobiliary disorders Cirrhosis alcoholic	0.33% 1/305 • 12 months
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.33% 1/305 • Number of events 305 • 12 months

Other adverse events
Measure	BLI400 Laxative n=305 participants at risk BLI400 Laxative BLI400 Laxative: oral laxative
Gastrointestinal disorders Diarrhea	7.5% 23/305 • Number of events 23 • 12 months
Gastrointestinal disorders Flatulence	5.2% 16/305 • Number of events 16 • 12 months

Braintree Laboratories, Inc.

Phone: 781-843-2202

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