Trial Outcomes & Findings for A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adolescent Subjects (NCT NCT02665728)

Last Updated: 2020-06-26

Results Overview

Overall treatment response is defined as weekly response in at least 2 out of 4 weeks. Weekly response is defined as greater than or equal to 3 spontaneous bowel movements during a week.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

4 weeks

Results posted on

2020-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	BLI400 BLI400 Laxative BLI400 Laxative
Overall Study STARTED	33
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adolescent Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BLI400 n=33 Participants BLI400 Laxative BLI400 Laxative
Age, Continuous	15.4 years STANDARD_DEVIATION 1.60 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Intent to Treat Population

Overall treatment response is defined as weekly response in at least 2 out of 4 weeks. Weekly response is defined as greater than or equal to 3 spontaneous bowel movements during a week.

Outcome measures

Outcome measures
Measure	BLI400 n=33 Participants BLI400 Laxative BLI400 Laxative
Treatment Response	32 Participants

Adverse Events

BLI400

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BLI400 n=33 participants at risk BLI400 Laxative BLI400 Laxative
Nervous system disorders headache	3.0% 1/33 • Number of events 1 • 4 weeks

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