Trial Outcomes & Findings for A Safety and Efficacy Evaluation of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation (NCT NCT02822508)

Last Updated: 2023-11-07

Results Overview

Treatment response is defined as 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 spontaneous bowel movements (SBMs) and an increase from baseline of \> 1 SBM in that week.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

434 participants

Primary outcome timeframe

12 weeks

Results posted on

2023-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	BLI801 Laxative (High Dose) BLI801 Laxative (high dose) BLI801 Laxative: BLI801 oral laxative	BLI801 Laxative (Mid Dose) BLI801 Laxative (mid dose) BLI801 Laxative: BLI801 oral laxative	BLI801 Laxative (Low Dose) BLI801 Laxative (low dose) BLI801 Laxative: BLI801 oral laxative	BLI801 Placebo BLI801 Placebo BLI801 Placebo: BLI801 oral laxative placebo
Overall Study STARTED	114	105	115	100
Overall Study COMPLETED	101	90	100	90
Overall Study NOT COMPLETED	13	15	15	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Safety and Efficacy Evaluation of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BLI801 Laxative (High Dose) n=114 Participants BLI801 Laxative (high dose) BLI801 Laxative: BLI801 oral laxative	BLI801 Laxative (Mid Dose) n=104 Participants BLI801 Laxative (mid dose) BLI801 Laxative: BLI801 oral laxative	BLI801 Laxative (Low Dose) n=114 Participants BLI801 Laxative (low dose) BLI801 Laxative: BLI801 oral laxative	BLI801 Placebo n=99 Participants BLI801 Placebo BLI801 Placebo: BLI801 oral laxative placebo	Total n=431 Participants Total of all reporting groups
Age, Continuous	55.6 years STANDARD_DEVIATION 9.03 • n=99 Participants	53.8 years STANDARD_DEVIATION 10.43 • n=107 Participants	53.4 years STANDARD_DEVIATION 10.62 • n=206 Participants	55.7 years STANDARD_DEVIATION 10.61 • n=7 Participants	54.6 years STANDARD_DEVIATION 10.19 • n=31 Participants
Sex: Female, Male Female	69 Participants n=99 Participants	69 Participants n=107 Participants	80 Participants n=206 Participants	71 Participants n=7 Participants	289 Participants n=31 Participants
Sex: Female, Male Male	45 Participants n=99 Participants	35 Participants n=107 Participants	34 Participants n=206 Participants	28 Participants n=7 Participants	142 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=99 Participants	9 Participants n=107 Participants	10 Participants n=206 Participants	4 Participants n=7 Participants	33 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	104 Participants n=99 Participants	95 Participants n=107 Participants	104 Participants n=206 Participants	95 Participants n=7 Participants	398 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: The Primary Efficacy Analysis Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	BLI801 Laxative (High Dose) n=114 Participants BLI801 Laxative (high dose) BLI801 Laxative: BLI801 oral laxative	BLI801 Laxative (Mid Dose) n=104 Participants BLI801 Laxative (mid dose) BLI801 Laxative: BLI801 oral laxative	BLI801 Laxative (Low Dose) n=114 Participants BLI801 Laxative (low dose) BLI801 Laxative: BLI801 oral laxative	BLI801 Placebo n=99 Participants BLI801 Placebo BLI801 Placebo: BLI801 oral laxative placebo
% of Subjects With Treatment Response Success	42 Participants	34 Participants	30 Participants	20 Participants
% of Subjects With Treatment Response Fail	72 Participants	70 Participants	84 Participants	79 Participants

Adverse Events

BLI801 Laxative (High Dose)

Serious events: 3 serious events

Other events: 24 other events

Deaths: 0 deaths

BLI801 Laxative (Mid Dose)

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

BLI801 Laxative (Low Dose)

Serious events: 3 serious events

Other events: 23 other events

Deaths: 0 deaths

BLI801 Placebo

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	BLI801 Laxative (High Dose) n=114 participants at risk BLI801 Laxative (high dose) BLI801 Laxative: BLI801 oral laxative	BLI801 Laxative (Mid Dose) n=104 participants at risk BLI801 Laxative (mid dose) BLI801 Laxative: BLI801 oral laxative	BLI801 Laxative (Low Dose) n=114 participants at risk BLI801 Laxative (low dose) BLI801 Laxative: BLI801 oral laxative	BLI801 Placebo n=99 participants at risk BLI801 Placebo BLI801 Placebo: BLI801 oral laxative placebo
Gastrointestinal disorders Abdominal distension	3.5% 4/114 • Number of events 4 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.96% 1/104 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	2.6% 3/114 • Number of events 3 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/99 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain	2.6% 3/114 • Number of events 3 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	2.9% 3/104 • Number of events 3 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.88% 1/114 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	3.0% 3/99 • Number of events 3 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	7.0% 8/114 • Number of events 8 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	2.9% 3/104 • Number of events 3 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	4.4% 5/114 • Number of events 5 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	1.0% 1/99 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.
Gastrointestinal disorders Flatulence	1.8% 2/114 • Number of events 2 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	2.9% 3/104 • Number of events 3 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	5.3% 6/114 • Number of events 6 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	5.1% 5/99 • Number of events 5 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.
Infections and infestations Sinusitis	0.88% 1/114 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.96% 1/104 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.88% 1/114 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	3.0% 3/99 • Number of events 3 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.
Infections and infestations Urinary tract infection	5.3% 6/114 • Number of events 6 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	2.9% 3/104 • Number of events 3 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	5.3% 6/114 • Number of events 6 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	5.1% 5/99 • Number of events 5 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.96% 1/104 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.88% 1/114 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	3.0% 3/99 • Number of events 3 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.

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
Publication restrictions are in place

Restriction type: OTHER

Measure	BLI801 Laxative (High Dose) n=114 participants at risk BLI801 Laxative (high dose) BLI801 Laxative: BLI801 oral laxative	BLI801 Laxative (Mid Dose) n=104 participants at risk BLI801 Laxative (mid dose) BLI801 Laxative: BLI801 oral laxative	BLI801 Laxative (Low Dose) n=114 participants at risk BLI801 Laxative (low dose) BLI801 Laxative: BLI801 oral laxative	BLI801 Placebo n=99 participants at risk BLI801 Placebo BLI801 Placebo: BLI801 oral laxative placebo
Psychiatric disorders Alcohol abuse secondary to worsening of depression and worsening of anxiety	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/104 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	1.0% 1/99 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.
Cardiac disorders Worsening of syncope	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.96% 1/104 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/99 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.
Nervous system disorders Encephalopathy	0.88% 1/114 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/104 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/99 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.
Cardiac disorders Worsening of atrial fibrilation	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/104 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.88% 1/114 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/99 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/104 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.88% 1/114 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/99 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.
Cardiac disorders Takotsubo cardiomyopathy	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/104 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.88% 1/114 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/99 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.
Psychiatric disorders Opioid withdrawal	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/104 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.88% 1/114 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/99 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Atypical chest pain of musculoskeletal origin	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/104 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.88% 1/114 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/99 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Worsening of chronic back pain	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.96% 1/104 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/99 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.
Hepatobiliary disorders Worsening of cholelithiasis	0.88% 1/114 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/104 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/99 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.
Cardiac disorders Chest pain substernal pressure	0.88% 1/114 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/104 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/99 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.
General disorders Exacerbation vertigo	0.88% 1/114 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/104 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/99 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.
Hepatobiliary disorders High ALT Values	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/104 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	1.0% 1/99 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.
Hepatobiliary disorders High AST Values	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/104 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	1.0% 1/99 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/114 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/104 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.88% 1/114 • Number of events 1 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.	0.00% 0/99 • 98 days The Adverse Event Population is based on the modified Intent-to-Treat population which includes patients who were randomized and took at least 1 dose of study medication.